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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
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed. The device was put through extensive testing without duplicating the report. The device was recertified and returned to the customer. The device activity log was cleared by the customer and could add no value to the investigation. No trend is associated with reports of this type.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device was unable to obtain an ecg signal. Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand NameX SERIES
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key6388837
MDR Text Key69749423
Report Number1220908-2017-00496
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112432
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Other Device ID Number00847946006341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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