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 06/11/2021

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 treat a patient (age & gender unknown), 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.

Manufacturer Narrative

The device was returned to zoll medical corporation.The customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.The device was recertified and returned to the customer.Reviewing the device logs, it is likely that case id (b)(4) is the event for the case.However, the case has no real information; there is no ecg signal, no electrode id, no errors, or evidence of trouble shooting.If the cpr adaptor is not applied (as seen by the onsite zoll representative), there would be no activity in the file as seen.It cannot firmly be determined that this was the cause of the report.There is not enough evidence to confirm or deny the report.The multifunction cable and accessories used were not returned as part of this investigation.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: 12103326
• MDR Text Key: 259572331
• Report Number: 1220908-2021-02048
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019167
• UDI-Public: 00847946019167
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death