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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORPORATION M SERIES DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number MSERIES BI-PHASIC
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2018
Event Type  Malfunction  
Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

 
Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown) in cardiac arrest, the device displayed "defib pad short and analysis halted" messages. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

 
Manufacturer Narrative

The customer was contacted for return of the suspect product. The product has not been returned to zoll for evaluation.

 
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Brand NameM SERIES
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key8227903
MDR Text Key132411053
Report Number1220908-2018-03862
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK990762
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberMSERIES BI-PHASIC
Device Catalogue NumberM SERIES
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2003
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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