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

Model Number X SERIES

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Necrosis (1971)

Event Date 02/08/2021

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation evaluated the device and the electrodes and the device performed to specification.The device was recertified and returned to the customer.The device was put through extensive testing including bench handling, ecg monitoring stress testing, and defib cycle testing without duplicating any malfunction to the device.The pads that were used during the event were returned stuck together and were compromised but did pass continuity testing.Review of the log did see evidence of the reported problem but does not indicate a device malfunction.The log showed the device is charged but is in a defib lead fault state and energy cannot be delivered.A defib lead fault indicates that a valid patient impedance was not detected through the pads.There are multiple factors outside of a device malfunction that could contribute to this condition.Some include, but are not limited to motion artifacts, poor contact between the pads and the patient's skin, poor contact between the multifunction cable and the adapter, or the patient's skin condition.This report has been attributed to poor coupling of the electrode pads to the patient's skin.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) 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.

• Brand Name: X SERIES
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 11407551
• MDR Text Key: 234548047
• Report Number: 1220908-2021-00562
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019297
• UDI-Public: 00847946019297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

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?: 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: 02/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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: 91 YR