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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 Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to zoll medical corporation. The customer's report was verified and the function switch was replaced to remedy the report. 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 switches settings on its own. Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand NameR SERIES DEFIBRILLATOR
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key12348430
MDR Text Key268811506
Report Number1220908-2021-02629
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060559/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
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 Manufacturer08/11/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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