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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Medical Device Problem Code Improper Alarm (2951)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional procode = dro.Evaluation results: the reported malfunction was observed during review of the activity logs.However, the reported problem could not be duplicated with the device.The processor/bridge/pace board was replaced as a precaution.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 the device displayed "defib disabled" and "pacer disabled" messages.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand Name
X SERIES
Common Device Name
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key6651905
Report Number1220908-2017-01458
Device Sequence Number11084139
Product Code MKJ
UDI-Device Identifier00847946018115
UDI-Public00847946018115
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K112432
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/07/2017
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 NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/07/2017
Initial Report FDA Received Date06/19/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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