MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR BLOWERS; SYSTEM, THERMAL REGULATING

Catalog Number EQ-5000-FR-230V

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that during a two hour operation under general anesthesia for a nephrectomy, the patient was placed under blanket heating with a heater set at 40 c.After a few minutes of intervention, the machine went into alarm.The health provider then checked the blanket and put it back on.The alarm went off and they continued to intervene.After a recheck a few minutes later, the provider noticed that the 6-7 cm diameter pipe, allowing the passage of air hot, had become very hot (about 60 c).The latter flattened and began to warp.The provider stopped the warmer and the operation continued as normal.At the end of the operation, the anesthesiologist realized that the patient had second degree burns on the back of the arm, and a little burn on the right shoulder.The current condition of the patient was described as follows: second degree burn estimated at approximately 4-5% of the body surface area.This required intervention in the operating room two days later for stripping/debridement.The heater and the hose were returned to the laboratory for analysis.The facility noted that preventive maintenance of the heater had been carried out by the device manufacturer.

Manufacturer Narrative

Initial report was reported as a malfunction.However, due to the surgical debridement that occurred a few days following initial incident, this complaint should have been reported as a serious injury as intervention was performed for preclude impairment.Device evaluation: one level 1 equator blower was returned for analysis.Upon visual inspection, the membrane switch was damaged, and the power cord was observed to not be the original.There were noted wear and tears to the enclosure.A hose and power cord were plugged in, 44 c was selected; with no temperature change.The enclosure was then knocked on and the temperature started to rise, reaching 55 degrees within 10-15 seconds.The membrane switch was noted to show 40 degrees and the over-temperature was triggered.A second attempt was performed, and 48 degrees was reached without the over temperature alarm being triggered.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10473903
• MDR Text Key: 206126758
• Report Number: 3012307300-2020-08841
• 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
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention