DRKClass III
Dc-defibrillator, High Energy, (including Paddles)
Cardiovascular · 21 CFR 870.5300
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
MDR events167All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
167 adverse event reports on file
- DC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES)Aug 12, 2023MalfunctionZollMW5141362
- LIFEPAK 15 MONITOR / DEFIBRILLATORMar 22, 2019DeathStryker8457056
- ZOLL M-SERIESFeb 25, 2019DeathZoll Medical Corp.8382081
- LIFEPAK(R) 5 DEFIBRILLATORAug 3, 2015MalfunctionPhysio-control, Inc3015876-2015-00949
- *Oct 23, 2013MalfunctionZoll Circulation3590850
- HEART-SYNCJan 26, 2011InjuryHeart-syncMW5019186
- LIFEPAK 6 DEFIBRILLATORAug 26, 2008MalfunctionPhysio-control, Inc.3015876-2008-01002
- LIFEPAK 6S PATIENT MONITORAug 18, 2008MalfunctionPhysio-control, Inc.3015876-2008-00958
- LIFEPAK 7 DEFIBRILLATOR/MONITORJan 18, 2008MalfunctionPhysio-control, Inc.3015876-2008-00692
- HEWLETT PACKARDJan 15, 2008OtherHewlett Packard (now Own By Philips Medical System Inc)982820
Event type breakdown
Malfunction81
Death49
Injury22
Unspecified13
Other2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code