MAUDE Adverse Event Report: SANMINA SCI CORPORATION WARMTOUCH SYSTEM, THERMAL REGULATING

Model Number 5016000

Device Problem Device Alarm System (1012)

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

Event Date 12/03/2020

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 presented a high priority alarm. There was no allegation of patient death or serious injury.

• Brand Name: WARMTOUCH
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SANMINA SCI CORPORATION; 202 lorong perusahaan maju 9; penang 13600 ; MY 13600
• Manufacturer (Section G): SANMINA SCI CORPORATION; 202 lorong perusahaan maju 9; penang 13600 ; MY 13600
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11086608
• MDR Text Key: 224123756
• Report Number: 2936999-2020-00980
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K123083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 5016000
• Device Catalogue Number: 5016000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown