ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
Check against the official notice below — it lists the full affected range.
Philips Electronics North America Corporation is recalling Philips sync cables (models M1783A and M5526A) and ECG out cables (model 989803195641) used with HeartStart MRx, HeartStart XL, and HeartStart XL+ monitor/defibrillators. When these cables transmit ECG signals from an auxiliary bedside monitor to a Philips monitor/defibrillator and the device experiences electrical fast transient (EFT) interference, the equipment may malfunction. On HeartStart MRx and XL models, EFT noise may be misinterpreted as an R-wave. On HeartStart XL+ models, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing, though this issue cannot occur if users follow the device's Instructions for Use, which require that the ECG cable be directly connected to the patient when performing demand mode pacing.
Approximately 15,811 recalled cables were distributed to 1,067 customers in the United States, 163 in Canada, and 917 internationally. The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave. " On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+.
Reason for recall: Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs): " On the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave. " On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+. Distribution: 1067 US customers 163 Canada, 917 International Quantity: 15811 Lot/code info: M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.