MAUDE Adverse Event Report: BLANKET WARMING CABINET; WARMER, IRRIGATION SOLUTION

Model Number GET2060

Device Problem Defective Device (2588)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Getinge maquet (b)(4) is not the legal manufacturer of this product.We have informed "enthermics medical systems" which is the legal manufacturer of this device and forwarded the facility medwatch to the legal manufacturer.Feel to contact us via the following mail address should you have any questions or need further information: (b)(4).

Event Description

We have received a facility medwatch report with the uf/importer report # (b)(4).In this report the blanket warming cabinet get2060 was claimed as defective product.It was stated that geeting sourcing, llc in (b)(4) was the legals manufacturer of this product.This is not true.Enthermics medical systems is the legal manufacturer of this device.We have forwarded the facility medwatch to endthermics medical systems.This case was registered in our complaint management system with reference # (b)(4).We have forwarded the facility medwatch report to the legal manufacturer.

• Brand Name: BLANKET WARMING CABINET
• Type of Device: WARMER, IRRIGATION SOLUTION
• MDR Report Key: 12735755
• MDR Text Key: 281097580
• Report Number: 8010652-2021-00031
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/02/2021

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
• Device Model Number: GET2060
• Device Catalogue Number: GET2060
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2021
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male