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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 Known Impact Or Consequence To Patient (2692)
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 a routine shift check by a clinician, the device displayed a "pacer fault 117" 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 Key5836893
MDR Text Key51177146
Report Number1220908-2016-01787
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
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 Number00847946012991
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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