MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. THERMOGARD XP; SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2020

Event Type  malfunction  

Event Description

Prior to using the device during the original intended procedure, the setup process failed and the device did not work as intended.A new device was obtained and subsequently applied on the patient functioning without any incident.

• Brand Name: THERMOGARD XP
• Type of Device: SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 10100786
• MDR Text Key: 192679142
• Report Number: 10100786
• Device Sequence Number: 1
• Product Code: NCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA