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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 BI-PHASIC
Device Problem Defibrillation/Stimulation Problem (1573)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during biomed testing, the device displayed a "pacer fault 116" message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.
 
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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 Key8029176
MDR Text Key125837547
Report Number1220908-2018-03145
Device Sequence Number1
Product Code DRO
UDI-Device Identifier00847946003609
UDI-Public00847946003609
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990762
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMSERIES BI-PHASIC
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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