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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 Device Operates Differently Than Expected (2913)
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 functional testing, the device was unable to obtain ecg signal via multifunction cable.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The complainant was contacted for return of the device.The customer has indicated that the multi-function cable was replaced and the faulty cable was dicarded.
 
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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 Key5341509
MDR Text Key35283344
Report Number1220908-2015-03411
Device Sequence Number1
Product Code DPS
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 12/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2016
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
Device Lot NumberN/A
Other Device ID Number00847946002886
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/18/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2007
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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