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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
Medical Device Problem Codes Pacing Problem (1439); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the device displayed a "pacer fault 117" and "defib fault 72" messages.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The customer has responded that the device has been removed from service and indicated the device will not be returning to zoll for evaluation.
 
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Brand Name
M SERIES
Common Device Name
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key10025757
Report Number1220908-2020-01239
Device Sequence Number3117124
Product Code MKJ
UDI-Device Identifier00847946000684
UDI-Public00847946000684
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K990762
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model NumberMSERIES BI-PHASIC
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/14/2020
Supplement Date Received by Manufacturer04/14/2020
Initial Report FDA Received Date05/05/2020
Supplement Report FDA Received Date05/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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