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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number R SERIES
Device Problems Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The reported malfunction was observed during review of the error logs.However, the reported problem could not be duplicated with the device.The analog board was replaced as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that during biomed testing, the device was unable to obtain ecg signal.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand Name
R SERIES DEFIBRILLATOR
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 Key5210725
MDR Text Key31039164
Report Number1220908-2015-02857
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 10/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberR SERIES
Device Catalogue NumberR SERIES
Other Device ID Number00847946002336
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/21/2015
Initial Date FDA Received11/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2008
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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