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

Model Number X SERIES

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Necrosis (1971); Insufficient Information (4580)

Event Date 07/30/2021

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 patient (age & gender unknown), the device failed to discharge.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.

Event Description

Complainant alleged that while attempting to defibrillate a 27-year-old male patient, the device failed to discharge.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Evaluation: the device was returned to zoll medical united kingdom.The customer's report was attributed to poor coupling.The device passed all testing without duplicating the report.Review of the device log suggests that there was likely poor coupling of the pads to the patient, that the users resolved at one point, but were unable to resolve at the end of the case.It is possible that cpr was a factor based on the dramatic variation in impedance readings, but this could not be firmly established, the cause of the poor coupling cannot be confirmed.It is important to note that the customer was using non-zoll pads during the rescue.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: 12388125
• MDR Text Key: 268812357
• Report Number: 1220908-2021-02842
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 27 YR