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 03/09/2024

Event Type  Death  

Event Description

Complainant alleged that while attempting to treat a 60-year-old female patient, the device was unable to obtain an ecg signal via defib 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 corporation for evaluation.The defib pads used during the event were not returned for evaluation.The device was put through extensive testing including bench handling, impedance, and defibrillation cycling using test accessories without duplicating the report.A review of the device log observed the ecg signal was never acquired through pads.The start of the case has two pads off messages with no pads on message.This indicates that the device is recognizing the pads are attached to the patient with an impedance between 300-580 ohms.In order to register a pads on message and obtain an ecg signal, the device must detect a valid impedance between 15-300 ohms.This indicates the pads are not making proper contact to the patient.Poor coupling can occur for multiple reasons, including but not limited to, electrode placement, skin preparation, and patient movement.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Zoll recommends that patients are cleaned and hair is clipped prior to applying electrode pads to assure good coupling of electrode to skin contact.The device was recertified and returned to the customer.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
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 19027826
• MDR Text Key: 339185834
• Report Number: 1220908-2024-01129
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946029616
• UDI-Public: 00847946029616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Female