MAUDE Adverse Event Report: GAYMAR GAYMAR; COOLING BLANKET

Model Number 901HBC5005

Device Problem Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 06/10/2014

Event Type  Injury  

Event Description

Cooling blanket was applied but water was not put into device by cna.Pt's temperature continued to rise and was sent to icu where temperature was lowered.Approximately 15 years old.

• Brand Name: GAYMAR
• Type of Device: COOLING BLANKET
• Manufacturer (Section D): GAYMAR; orchard park 1407 5
• MDR Report Key: 3906271
• MDR Text Key: 4654229
• Report Number: MW5036934
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 901HBC5005
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 55