MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE SYSTEM, THERMAL REGULATING

Catalog Number CON-EQ-5000

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

The customer reported that the hose was missing the air diffuser on the equator® convective warmer that resulted in a light burn to the inner thigh. Additional information was requested but no additional information was reported on degree of burn or if an intervention was needed.

Manufacturer Narrative

One device was received for investigation. The device was received without the hose or power supply. A review of the device history record, for the reported serial number, found that the device had been received in the past for repairs and was originally used as a demonstration device. Visual inspection found that the device and filter were in good condition. During functional testing, a known good hose and power cord were attached to the warming device and the unit was plugged in. The device performed its self-test with no issues observed. The device was set to each of its three different temperature settings; all temperatures were found within specification. The temperature was then measured while the device was 75% and 100% occluded; the device passed both tests. The warming device was forced into over and under temperature and at each temperature setting; the device passed all tests. During all three forced overheating simulations, the alarm sounded and the warming device shut itself off within temperature specifications. The device was then set to each of its three different temperature settings for an extended period of time; all temperatures remained within specification. As the returned device operated in specification, no evidence was found to suggest the reported event was related to an intrinsic product fault. (b)(4). Please note, investigation results for mfr# 2183502-2016-01656 was originally submitted under mfr#: 2183502-2016-01655. Supplemental report sent to correct error.

• Brand Name: LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL OAKDALE; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5843504
• Report Number: 2183502-2016-01656
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CON-EQ-5000
• Device Lot Number: S10004711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage