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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

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ZOLL MEDICAL CORPORATION PROPAQ MD DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number PROPAQ MD
Device Problem Delivery System Failure (2905)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2014
Event Type  malfunction  
Event Description
Complainant alleged that while attempting to treat a patient (age and gender unk), the device's display was missing clinical information.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.Complainant indicated that subsequent testing did not duplicate the reported malfunction.
 
Manufacturer Narrative
Zoll medical corp has not received the device for evaluation and this complaint is still under investigation.
 
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Brand Name
PROPAQ MD DEFIBRILLATOR
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key3924913
MDR Text Key4668915
Report Number1220908-2014-01529
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 Unknown
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2014
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? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2012
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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