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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number MSERIES
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
 
Event Description
Complainant alleged that during biomed testing the device displayed a "pacer fault 117" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty safety relay on the hv module assembly.Analysis for reports of this type has not identified an increase in trend.
 
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Brand Name
M SERIES
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 Key5239832
MDR Text Key31998579
Report Number1220908-2015-03027
Device Sequence Number1
Product Code DRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972241
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMSERIES
Device Catalogue NumberM SERIES
Other Device ID Number00847946013905
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received11/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/1999
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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