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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 No Display/Image (1183)
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 half of the screen.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The customer's report was observed and attributed to a faulty el display.The el display was replaced to resolve the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
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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 Key9955266
Report Number1220908-2020-00935
Device Sequence Number690006
Product Code MKJ
UDI-Device Identifier00847946002886
UDI-Public00847946002886
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) 03/23/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/23/2020
Supplement Date Received by Manufacturer03/23/2020
Initial Report FDA Received Date04/13/2020
Supplement Report FDA Received Date05/29/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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