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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 CCT
Device Problems Unable to Obtain Readings (1516); Unexpected Shutdown (4019)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Additional pro code: mkj. Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

 
Event Description

Complainant alleged that during functional testing, the device displayed a "poor pad contact" message and inappropriately shut down. Complainant did not indicate that there was any patient involvement in the reported malfunction.

 
Manufacturer Narrative

The device was returned to zoll medical (b)(4); the reported malfunction for device shut down was duplicated and the ac power cord was replaced to remedy the problem. The device was recertified and returned to the customer. The reported malfunction for device displayed "poor pad contact" was evaluated and communication with the customer indicated there were no electrode pads attached at the time. This is normal operation of the device if there are no pads connected to the device. No trend is associated with reports of this type.

 
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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 Key9177476
MDR Text Key161984653
Report Number1220908-2019-03024
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK011865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberMSERIES CCT
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 Received09/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2009
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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