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 07/25/2021

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 obtain an ecg signal via electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical united kingdom.The customer's report was not replicated or confirmed.The device passed all testing without duplicating the report.Review of the device log shows that electrodes were applied.It takes several minutes to acquire an ecg signal with some troubleshooting.A second set of electrodes was most likely utilized.The ecg signal is present for 90 consecutive minutes and was a clean, strong signal.Without the return of the electrodes used, it cannot be determined if there was a concern with the electrodes, application of the electrodes, patient preparation, or other factor that would prevent or inhibit the acquisition of an ecg signal.The electrodes used were not retained and were unavailable for evaluation.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: 12488355
• MDR Text Key: 271911162
• Report Number: 1220908-2021-03125
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 53 YR