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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 Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device did not have pacer output.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The customer was contacted for return of the suspect product.The customer has responded and indicated the product will not be returning to zoll.
 
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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 Key5246749
MDR Text Key32123736
Report Number1220908-2015-03079
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
Type of Report Initial,Followup
Report Date 11/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2015
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 Number00847946004170
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2006
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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