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

Model Number 5016000-RC

Device Problems Use of Device Problem (1670); Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): CELSIUS MEDICAL S.L; ctra. de ajalvir, km 5,200; ajalvir 28864 ; ES 28864
• Manufacturer (Section G): CELSIUS MEDICAL S.L; ctra. de ajalvir, km 5,200; ajalvir 28864 ; ES 28864
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9934404
• MDR Text Key: 187380447
• Report Number: 2936999-2020-00259
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10884521190672
• UDI-Public: 10884521190672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5016000-RC
• Device Catalogue Number: 5016000-RC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1