FDA Adverse Event
Injury
Summary report: N
HME BOOSTER
MDR report key: 798554
·
Received December 21, 2006
Report
- Report Number
- 1824226-2006-00001
- Event Type
- Injury
- Date Received
- December 21, 2006
- Date of Event
- December 13, 2006
- Report Date
- December 19, 2006
- Manufacturer
- KING SYSTEMS CORP.
- Product Code
- BTT
- PMA / PMN Number
- K990614
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. KING SYSTEMS CAN NOT DUPLICATE THIS TYPE OF EVENT UNLESS INSTRUCTIONS FOR USE ARE NOT FOLLOWED.
Description of Event or Problem · 1
THE USER-FACILITY REPORTED: PATIENT FOUND WITH 2-3 INCH BURN TO LEFT DELTOID AREA. VENTILATOR HEAT SENSOR (HME BOOSTER) VERY HOT TO TOUCH, NOTED TO BE TOUCHING DELTOID AREA WHEN BURN FOUND. THE PATIENT SUFFERED 3RD DEGREE BURN. WILL POSSIBLY REQUIRE EXCISION AND SKIN GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HME BOOSTER | HEATER | BTT | KING SYSTEMS CORP. | MSB-600 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention| S |