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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 Code Pacing Problem (1439)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The reported malfunction and attributed the failure to an open wire (pin 2 patient end to pin 4 device end)-ground shield wire within the multi-function cable.The multi-function cable was replaced to resolve the malfunction.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during biomed testing, the device's pacer output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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 Key8757278
Report Number1220908-2019-01773
Device Sequence Number1330264
Product Code DRO
UDI-Device Identifier00847946013417
UDI-Public00847946013417
Combination Product (Y/N)N
Initial Reporter StateCA
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
Report Date (Section B) 06/12/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/12/2019
Initial Report FDA Received Date07/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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