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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 Failure to Charge (1085)
Patient Problem No Information (3190)
Event Date 11/27/2020
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 while attempting to defibrillate a patient (age & gender unknown), the device failed to charge.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation.The customer's report was duplicated and attributed to the battery lug nuts being loose.The lug nuts were replaced to address the customer report.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 Key11037524
MDR Text Key222336668
Report Number1220908-2020-04063
Device Sequence Number1
Product Code MKJ
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 11/30/2020
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 NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received11/30/2020
Supplement Dates FDA Received01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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