FDA Adverse Event
Death
Summary report: N
OXYGEN COMPRESSED GAS M6 TANK
MDR report key: 7633603
·
Received April 27, 2018
Report
- Report Number
- 7633603
- Event Type
- Death
- Date Received
- April 27, 2018
- Date of Event
- April 20, 2018
- Report Date
- April 27, 2018
- Manufacturer
- MEDCYL
- Product Code
- CAW
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
(B)(6) SW MADE VISIT ON (B)(6) 2018 AND WAS NOTIFIED BY (B)(6) THAT PT WAS AIRLIFTED TO (B)(6) ON (B)(6) 2018 DUE TO BURNS ON FACE AND ARMS. (B)(6) STATES PT TURNED OFF O2 BUT DIDN'T WAIT TO SMOKE. SPOKE WITH OPERATOR AT (B)(6) WHO CONFIRMED PT ADMIT DATE (B)(6) 2018 AND DEATH DATE (B)(6) 2018. LOCAL POLICE REPORT STATED THAT PT WAS INJURED BY MINOR EXPLOSION/FIRE AND SUFFERED THIRD DEGREE BURNS. EITHER OXYGEN E TANK OR M6 TANK WAS INVOLVED IN PT INJURY/DEATH, UNABLE TO ASCERTAIN FOR SURE BECAUSE WE ARE UNABLE TO ENTER HOME TO INVESTIGATE EQUIPMENT. REF UF# (B)(4) FOR OXYGEN CYLINDER M6 TANK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313873 | OXYGEN COMPRESSED GAS M6 TANK | OXYGEN COMPRESSED GAS M6 TANK | CAW | MEDCYL | 1180955 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death| H | HUMIDIFIER ADAPTER| NEB KIT, AEROSOL MASK| NEBULIZER| O2 CART| OCD| OCD POUCH| OXYGEN WRENCHES| REGULATOR |