MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL INNERCOOL STX SURFACE SYSTEM; THERMAL REGULATING SYSTEM

Model Number 8700-00836-01

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Use of Device Problem (1670)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

Samantha davis called from women's hospital in baton rouge, la to report an innercool stx surface system (120v) (sn (b)(6).That isn't working.This is a new site, and she's on site doing in-servicing for the first time before their go-live this week.She reported that when turning the device on, she's getting a green light, but the display is black.The zoll clinical field educator gave her the gentherm phone # for troubleshooting.She called gentherm and they told her it was a "faulty display circuit board" and that it needed to go to biomed for repair.Shane in biomed at woman's hospital baton rouge called gentherm and was able to replace the small class circuit bulb and the machine was operational.However, two days later, during training to the nursing staff, the same issue occurred when the console was powered on.None of the buttons would work.The gentherm tech explained that it was a faulty circuit board and put in a request to overnight the hospital a new circuit board for replacement.No patient involvement.

Manufacturer Narrative

The innercool stx surface system (120v) (sn (b)(6)) involved in the reported complaint will not be returned to a zoll service depot for evaluation.The device was investigated and serviced by gentherm and the biomed at the customer site.The failed circuit board was replaced to remedy the blank/unresponsive display issue.The system is back in service.Since the issue were resolved, service was not required to be performed by zoll.

• Brand Name: ZOLL INNERCOOL STX SURFACE SYSTEM
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17941178
• MDR Text Key: 325842634
• Report Number: 3010617000-2023-00872
• Device Sequence Number: 1
• Product Code: FOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2023

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: Health Professional
• Device Model Number: 8700-00836-01
• Device Catalogue Number: 8700-00836-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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