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

Model Number 5000HF

Device Problems Device Sensing Problem (2917); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Type  Injury  

Event Description

It was reported that a patient was blistered while using a smiths medical warmer.No further adverse patient effects were reported.

Manufacturer Narrative

Investigation completed on convective warming|level 1 equator blowers the complaint of patient suffered blisters in upper arm with blank warmer on during an operation was not confirmed.The device was tested upon power on for three hours and unable to replicate event.The physical condition of device revealed wear and tear damage to membrane switch, top and bottom enclosure.Previous repair in (b)(6) 2019, the device was in for temperature fluctuates.But the temperature problem was not duplicated.The impeller was found to be grinding and it was replaced.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped due to age of the device, therefore membrane switch, top and bottom enclosure damage will not be repaired.

Manufacturer Narrative

Other, other text: investigation completed on convective warming|level 1 equator blowers the complaint of patient suffered blisters in upper arm with blank warmer on during an operation was not confirmed.The device was tested upon power on for three hours and unable to replicate event.The physical condition of device revealed wear and tear damage to membrane switch, top and bottom enclosure.Previous repair in (b)(6) 2019, the device was in for temperature fluctuates.But the temperature problem was not duplicated.The impeller was found to be grinding and it was replaced.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped due to age of the device, therefore membrane switch, top and bottom enclosure damage will not be repaired.

Event Description

Investigation completed with summary in h 10.

• Brand Name: LEVEL 1
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11418845
• MDR Text Key: 234883221
• Report Number: 3012307300-2021-01757
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5000HF
• Device Catalogue Number: CON-EQ-5000HF-115V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 07/22/2021; 07/22/2021
• Supplement Dates FDA Received: 08/21/2021; 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other