MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 EQUATOR BLOWERS; SYSTEM, THERMAL REGULATING

Catalog Number SW5-HOSE-7

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Manufacture and expiry information could not be determined with information provided.

Event Description

It was reported that the during an abdominoperineal amputation, the patient sustained burns and blisters (phlyctene) at the arms and chest, following use of the equator warming blanket.The traces of burns had been observed at the removal of the drapes.With the current information available it is not clear whether any treatment was required to preclude permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

One hose from the device was returned for evaluation.Hose was received in used condition and connected to known good test device.Device and hose functioned as intended.Customer complaint was not confirmed.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7537127
• MDR Text Key: 109017594
• Report Number: 3012307300-2018-01633
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 50695085000653
• UDI-Public: 50695085000653
• Combination Product (y/n): N
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: SW5-HOSE-7
• Device Lot Number: N2070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR