MAUDE Adverse Event Report: CELSIUS MEDICAL S.L WARMTOUCH; SYSTEM, THERMAL REGULATING

Model Number	5016000-RC
Medical Device Problem Codes	Use of Device Problem (1670); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit's cursor was constantly moving and it had an overheat alarm.The failure was isolated to the device.There was no patient involvement.

• Brand Name: WARMTOUCH
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): CELSIUS MEDICAL S.L; ctra. de ajalvir, km 5,200; ajalvir 28864 ; ES 28864
• MDR Report Key: 9934404
• Report Number: 2936999-2020-00259
• Device Sequence Number: 701095
• Product Code: DWJ
• UDI-Device Identifier: 10884521190672
• UDI-Public: 10884521190672
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5016000-RC
• Device Catalogue Number: 5016000-RC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1