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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Device Problem Mechanics Altered (2984)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that during biomed testing, the device was unable to switch modes.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The customer's report was not replicated or confirmed.The device was put through extensive testing including power cycling into neonate mode without duplicating the report.Review of the device log indicated that the device operated as intended.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
X SERIES
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key10830410
MDR Text Key215956603
Report Number1220908-2020-03566
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946019181
UDI-Public00847946019181
Combination Product (y/n)N
PMA/PMN Number
K112432/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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