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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 Problem Failure to Analyze Signal (1539)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The reported malfunction was observed and attributed to a lifted pad on the analog board.Analysis of reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that during functional testing, the device was unable to obtain an ecg signal via electrode pads.Complainant did not indicate that there was any 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 Key6723464
MDR Text Key80384498
Report Number1220908-2017-01707
Device Sequence Number1
Product Code DRT
UDI-Device Identifier00847946017163
UDI-Public00847946017163
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 07/05/2017
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/05/2017
Initial Date FDA Received07/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
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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