MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER

Model Number X SERIES

Device Problem Unable to Obtain Readings (1516)

Patient Problem Necrosis (1971)

Event Date 07/31/2021

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) year-old male patient, the device was unable to detect the attached electrode pads.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the clinical file of the customer's report was provided.Review of the clinical file shows that the user entered pacer mode, which will prevent the selection and viewing of the pads lead.This is by design and is normal operation of the device.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 12498516
• MDR Text Key: 272247198
• Report Number: 1220908-2021-03021
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946005993
• UDI-Public: 00847946005993
• Combination Product (y/n): N
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR