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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORP PROPAQ MD DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORP PROPAQ MD DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number PROPAQ MD
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2014
Event Type  malfunction  
Event Description
Complainant alleged that while attempting to treat a pt the device displayed a "pacer fault" message.Complainant indicated that the clinician obtained another device to continue treating the pt.Complainant did not indicate that there was any adverse effect to the pt due to the reported malfunction.
 
Manufacturer Narrative
Zoll medical corp has received the product and will be providing a following-up report when our investigation is completed.
 
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Brand Name
PROPAQ MD DEFIBRILLATOR
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORP
chelmsford MA
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key4001971
MDR Text Key4955474
Report Number1220908-2014-01679
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPROPAQ MD
Device Catalogue NumberPROPAQ MD
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/18/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2014
Was Device Evaluated by Manufacturer? No
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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