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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 Unable to Obtain Readings (1516)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation; visual evaluation of the device found damage consistent with tampering.Due to the condition in which the device was received, root cause analysis could not be performed.A system interconnect flex cable was replaced to remedy the problem.The device was repaired and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during functional testing, the device was unable to obtain an ecg signal via electrode pads.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 Key9530515
Report Number1220908-2019-04024
Device Sequence Number16838539
Product Code DRT
UDI-Device Identifier00847946001964
UDI-Public00847946001964
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K060559/P160
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/10/2019
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 NumberR SERIES
Device Catalogue NumberR SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/10/2019
Initial Report FDA Received Date12/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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