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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number R SERIES
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The customer's report was observed and attributed to a damaged trace on a fuse on the battery interconnect board.The battery interconnect board was replaced and scrapped to resolve the report.The device was receritified 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 a routine shift check by a clinician, the device would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand Name
R SERIES DEFIBRILLATOR
Common Device Name
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key11496709
Report Number1220908-2021-00803
Device Sequence Number4846177
Product Code MKJ
UDI-Device Identifier00847946017309
UDI-Public00847946017309
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K060559/P160
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/01/2021
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 Health Professional
Device Model NumberR SERIES
Device Catalogue NumberR SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/01/2021
Initial Report FDA Received Date03/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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