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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 Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Complainant alleged that during biomed testing, the device did not have pacer output.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, environmental chamber testing, and functional testing without duplicating the report.The device was recertified and returned to the customer.Review of the logs did not provide evidence of any pacer related faults.Analysis of reports of this type has not identified an increase in trend.
 
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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
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key17498630
MDR Text Key320784318
Report Number1220908-2023-03072
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 07/20/2023
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 Manufacturer07/26/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/20/2023
Initial Date FDA Received08/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2011
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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