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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 Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
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 while attempting to treat a patient (age & gender unknown), the device displayed a "error 95" message.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The customer has responded and indicated the device was repaired and the replaced pace/defib engine board was discarded onsite.The device will not be returning to zoll.
 
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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 Key8778006
Report Number1220908-2019-01852
Device Sequence Number1977424
Product Code MKJ
UDI-Device Identifier00847946002572
UDI-Public00847946002572
Combination Product (Y/N)N
Initial Reporter StateFL
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,Followup
Report Date (Section B) 06/19/2019
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? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/19/2019
Supplement Date Received by Manufacturer06/19/2019
Initial Report FDA Received Date07/10/2019
Supplement Report FDA Received Date08/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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