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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 Problems Use of Incorrect Control/Treatment Settings (1126); Pacing Problem (1439)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to zoll medical corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing, which included environmental and functional testing without duplicating the report.The device was recertified and returned to the customer.No trend is associated with reports of this type.
 
Event Description
Complainant alleged that during biomed testing, the device's pacing values were incorrect and the device was not pacing properly.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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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 Key5101825
MDR Text Key26832228
Report Number1220908-2015-02473
Device Sequence Number1
Product Code DRO
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
Report Date 09/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2015
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
Other Device ID Number00847946003609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2000
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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