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

Model Number X SERIES

Device Problems Unable to Obtain Readings (1516); Use of Device Problem (1670); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional pro code: mkj.Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that during functional testing, the device was unable to obtain an ecg signal and displayed unknown error messages.Complainant did not indicate that there was any patient involvement in the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Device evaluation: the reported malfunction of the device was unable to recognize a battery was installed and inappropriately indicated ac power was duplicated and the battery connection assembly was replaced to resolve the malfunction.The device was recertified and returned to the customer.The reported malfunction of unknown error message was not replicated or confirmed.The device was put through extensive testing which included bench handling and full functional stress testing without any error messages.Review of the error logs did not find evidence to support the reported event.Review of the device log did see occurrences of nibp cuff block messages.Reports of this nature are typically not considered to have any clinical impact.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that during functional testing, the device the device was unable to recognize a battery was installed and inappropriately indicated ac power.Complainant did not indicate that there was any patient involvement in the reported malfunction.

• 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: 8214346
• MDR Text Key: 131986711
• Report Number: 1220908-2018-03810
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 00847946004354
• UDI-Public: 00847946004354
• 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
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• 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: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1