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

Model Number X SERIES

Device Problem Pacing Problem (1439)

Patient Problem Death (1802)

Event Date 07/23/2017

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.

Event Description

Complainant alleged that while attempting to treat a (b)(6) old male patient in cardiac arrest, the associated multi-function cable was inadvertently disconnected from the defibrillator while attempting to pace the patient.Complainant indicated that the patient arrested as they went through the doors of the hospital and the patient subsequently expired.

Manufacturer Narrative

Zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.Review of the device activity log confirmed that the multi-function cable became disconnected during the reported patient event causing the pacer function to stop.The fault was cleared by reconnecting the multi-function cable to the device and the pacer function resumed as normal.It could not be firmly established how the cable became disconnected during the event.The multi-function cable was inspected and tested.No damage was seen and the locking mechanism functioned properly.The customer was provided with an instruction sheet as a precaution, with pictures depicting how to attach the cable to the receptacle and then turn the locking mechanism to the right.Analysis of reports of this type has not identified an increase in trend.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on supplemental medwatch report 001.Evaluation results: the reported malfunction was observed during review of the activity logs.However, the reported problem could not be duplicated with the device.The device was recertified and returned to the customer.Review of the device activity log confirmed that the multi-function cable became disconnected during the reported patient event causing the pacer function to stop.It cannot be determined if the multi-function cable was not fully engaged prior to the incident or if it was disengaged during the incident.The fault was cleared by reconnecting the multi-function cable to the device and the pacer function resumed as normal.The multi-function cable was inspected and tested.No damage was seen and the locking mechanism functioned properly.The customer was provided with an instruction sheet as a precaution, with pictures depicting how to attach the cable to the receptacle and then turn the locking mechanism to the right.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: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 6795466
• MDR Text Key: 82724333
• Report Number: 1220908-2017-01901
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00847946005993
• UDI-Public: 00847946005993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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: 08/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 07/26/2017; 07/26/2017
• Supplement Dates FDA Received: 12/20/2017; 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: 72 YR