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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
Device Problem Improper Alarm (2951)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device displayed a "defib fault 72" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
 
Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed.The device was put through extensive testing without duplicating the malfunction.Review of the device history log provided evidence of the customer's report.The device was recertified and returned to the customer.No trend is associated with reports of this type.
 
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Brand Name
R SERIES DEFIBRILLATOR
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key6693043
MDR Text Key79270168
Report Number1220908-2017-01567
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946002336
UDI-Public00847946002336
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 06/19/2017
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
Device Operator Other
Device Model NumberR SERIES
Device Catalogue NumberR SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/19/2017
Initial Date FDA Received07/07/2017
Supplement Dates Manufacturer Received06/19/2017
06/19/2017
Supplement Dates FDA Received07/28/2017
08/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2008
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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