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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 Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device inappropriately shut down.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The malfunction was duplicated and the monitor board was replaced to resolve the malfunction.The customer declined repair of the device.The device was returned to the customer labeled "not for clinical use".Analysis of reports of this type has not identified an increase in trend.
 
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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 Key7475204
MDR Text Key106970039
Report Number1220908-2018-01152
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946017651
UDI-Public00847946017651
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,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2011
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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