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

Model Number EQ-5000

Device Problems Material Separation (1562); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

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.Device evaluation in progress.

Event Description

The user facility reported that the device was in use with an infant when the seals between the perforations in the lower section of the blanket separated, which resulted in a large air filled balloon at the feet of the patient.According to the reporter, the event resulted in the redness of the patient's skin.The reporter stated that the warmer was set to a medium temperature and no alarms sounded during the event.According to the reporter, the patient did not sustain adverse permanent injury.The reporter stated that the warming blanket was disposed of; however, a blanket of the same lot is available for investigation.

• 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 ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5727896
• MDR Text Key: 47486656
• Report Number: 2183502-2016-01186
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQ-5000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other