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

Model Number X SERIES

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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 a routine shift check by a clinician, the device's display showed a blue line down the screen and was not legible.Complainant indicated that there was no patient involvement in the reported malfunction.

Event Description

Complainant alleged that during a routine shift check by a clinician, the device's display showed a blue line down the screen, but the screen was still legible.Complainant indicated that there was no 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.Please reference sections b5 and h6:device problem code.Evaluation results: the device was returned to zoll medical corporation for evaluation.The customer's report was observed and attributed to the lcd display.The lcd display was replaced to resolve the report.Analysis of reports of this type has not identified an increase in trend.Reports of this nature are typically not considered to be medwatch reportable as there is no potential for clinical impact.The screen and critical information was still visibale to the user.

• 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: 16491372
• MDR Text Key: 310784604
• Report Number: 1220908-2023-00681
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019402
• UDI-Public: 00847946019402
• 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,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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