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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORP M SERIES DEFIBRILLATOR/PACEMAKER

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ZOLL MEDICAL CORP M SERIES DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number MSERIES
Device Problem Failure to Discharge (1169)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Event Description

Complainant alleged that during a routine shift check by a clinician, the device failed to discharge. Complainant indicated that there was no pt involvement in the reported malfunction.

 
Manufacturer Narrative

Zoll medical corp has received the product and will be providing a follow-up report when our investigation is completed.

 
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Brand NameM SERIES
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORP
chelmsford MA
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key4507157
MDR Text Key5412135
Report Number1220908-2015-00184
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK972241
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/14/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMSERIES
Device Catalogue NumberM SERIES
OTHER Device ID Number00847946006990
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/19/2015
Is The Reporter A Health Professional? No
Date Manufacturer Received01/14/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/01/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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