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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR Back to Search Results
Model Number PROPAQ MD
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty transformer on the processor/bridge/pace board.Analysis for reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that during biomed testing the device's pacer test failed.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand Name
PROPAQ MD DEFIBRILLATOR
Type of Device
PROPAQ MD
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key5539227
MDR Text Key41777455
Report Number1220908-2016-00833
Device Sequence Number1
Product Code DRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 03/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberPROPAQ MD
Device Catalogue NumberPROPAQ MD
Device Lot NumberN/A
Other Device ID Number00847946017651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received03/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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