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

Model Number X SERIES

Device Problem Pacing Problem (1439)

Patient Problem Necrosis (1971)

Event Date 01/21/2021

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 pace a (b)(6) female patient, the device was unable to pace.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 passed pacer output testing, bench handling, and a defib cycle run without duplicating the report.Review of the device logs added no value as the logs were cleared after the incident.The device was recertified and returned to the customer.It is important to note that patient reaction is not always guaranteed when delivering therapy.Even though muscle contractions are typical, the device cues and identifiers should be used to confirm hat the device is outputting correctly.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: 11322701
• MDR Text Key: 231638997
• Report Number: 1220908-2021-00364
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019372
• UDI-Public: 00847946019372
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 03/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR