Covidien: Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN

Hazard

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

Details from the source

Reason for recall: Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting Distribution: Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR, WA, SD, KY, DE, NJ, UT, NV, MA, MT, GU, NE, LA, HI, OR, RI, NH, ND, NM, ME, CT, DC, WY and the countries of Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bhutan, Bolivia, Quantity: 264,790 Lot/code info: REF/UI-DI/Bundle Code/IFU Part Number: PM100N/10884521196728/NELL-HOMECARE, BNPULSOKSYMETR, PM100N, PM100NKIT, PM100NKITCHDE, PM100NKITCHFR, PM100NKITDA, PM100NKITDE-2, PM100NKITES, PM100NKITFI, PM100NKITFR, PM100NKIT-FR, PM100NKITIT, PM100NKIT-NL, PM100NKITNO, PM100NKITPT, PM100NKITSV, PM100NKITUK, PM100N-10, PM100N-2XMAXN, PM100N-2XMAXN-CC, PM100N-3DYS-CC, PM100N-DYS, PM100N-HC, PM100N-MAXN, PM100N-MAXN-CC, PM100N-OXIAN-CC/PT00156589 - AR - Arabic, PT00156609 - AR - Arabic, PT00156588 - BG - Bulgarian, PT00156610 - BG - Bulgarian, PT00156586 - CS - Czech, PT00156612 - CS - Czech, PT00156585 - DA - Danish, PT00156613 - DA - Danish, PT00156578 - DE - German, PT00156625 - DE - German, PT00156577 - EL - Greek, PT00156626 - EL - Greek, PT00156509 - EN - English, PT00156328 - EN - English, PT00156563 - ES - Spanish, PT00156639 - ES - Spanish, PT00156583 - ET - Estonian, PT00156615 - ET - Estonian, PT00156582 - FI - Finnish, PT00156616 - FI - Finnish, PT00156581 - FR - French, PT00156617 - FR - French, PT00156587 - HR - Croatian , PT00156611 - HR - Croatian , PT00156576 - HU - Hungarian, PT00156627 - HU - Hungarian, PT00156575 - IT - Italian, PT00156628 - IT - Italian, PT00156580 - KA - Georgian, PT00156618 - KA - Georgian, PT00156591 - KO - Korean, PT00156642 - KO - Korean, PT00156573 - LT - Lithuanian, PT00156630 - LT - Lithuanian, PT00156574 - LV - Latvian, PT00156629 - LV - Latvian, PT00156584 - NL - Dutch, PT00156614 - NL - Dutch, PT00156572 - NO - Norwegian, PT00156631 - NO

UPC codes

10884521196728, 10884521163454, 10884521527607, 10884521173293, 10884521171534, 884521512019, 884521188689

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.