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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 Death (1802)
Event Date 02/15/2019
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) year-old male patient, the device displayed a "defib pad short" message. Complainant indicated that the clinician obtained another device and electrode pads to continue treating the patient and received the same error. Complainant indicated that the patient subsequently expired. Please reference medwatch report 1220908-2019-00648 for the another defibrillator used in the event.

 
Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device. This supplemental medwatch report is also correcting information submitted on the initial medwatch report. Evaluation results: the complainant was contacted for return of the device. The customer has responded and indicated the device is working fine and the will not be returning to zoll.

 
Manufacturer Narrative

Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed. The device was put through extensive testing which included bench handling, multiple 30 joules self-tests, shock testing at various joules settings utilizing the returned multifunction cable and continuity testing without duplicating the reported malfunction. The device's biphasic cable was replaced as a precaution. The device was recertified and returned to the customer. No trend is associated with reports of this type. Please refer to the attached user medwatch report that zoll medical has received.

 
Manufacturer Narrative

Additional information: inadvertently did not attach user medwatch report.

 
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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 Key8420085
MDR Text Key138771656
Report Number1220908-2019-00628
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,Followup,Followup
Report Date 02/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberMSERIES BI-PHASIC
Device Catalogue NumberM SERIES
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Report Sent to FDA02/20/2019
Distributor Facility Aware Date02/15/2019
Event Location Hospital
Date Report TO Manufacturer02/19/2019
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/14/2019 Patient Sequence Number: 1
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