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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR Back to Search Results
Model Number E SERIES
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during functional testing, the device displayed a "pacer fault 117" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical (b)(4)'s service department and the reported malfunction was observed during review of the activity log.However, the reported problem could not be duplicated with the device.The hv module was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.
 
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Brand Name
E SERIES DEFIBRILLATOR
Type of Device
E SERIES
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key5664321
MDR Text Key45777205
Report Number1220908-2016-01182
Device Sequence Number1
Product Code DRO
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K042007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberE SERIES
Device Catalogue NumberE SERIES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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