FDA Adverse Event
Injury
Summary report: N
REGULATOR
MDR report key: 5725677
·
Received June 15, 2016
Report
- Report Number
- 1062191-2016-00001
- Event Type
- Injury
- Date Received
- June 15, 2016
- Date of Event
- April 30, 2016
- Report Date
- June 15, 2016
- Manufacturer
- INNOVO, INC
- Product Code
- CAN
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- EMERGENCY MEDICAL TECHNICIAN
Narratives
Additional Manufacturer Narrative · 1
THE UNIT BT3125-R WAS RETURNED TO THE MANUFACTURER 05/23/2016. THE UNIT WAS EVALUATED AND HAD BEEN FIELD ALTERED FROM ITS ORIGINAL CONFIGURATION. THE ALTERATION REPLACED THE NPT SEALING PLUG IN AN UNREGULATED HIGH PRESSURE PORT WITH A PTO FITTING AND LOW PRESSURE (50 PSI) THIRD PARTY CPAP ACCESSORY.
Description of Event or Problem · 1
EMT MEDIC WENT TO TRANSFER PATIENT FROM AMBULANCE TO EMERGENCY DEPARTMENT. THE EMT SWITCHED TO PORTABLE O2 AND CONNECTED THE CPAP TO A NEW CYLINDER. THE CPAP RESUMED OPERATION AND THEN A "POP" SOUND OCCURRED FOLLOWED BY A FLASH FIRE, "THAT LASTED A FEW SHORT SECONDS". THE PATIENT WAS NOT INJURED, THE EMT EXPERIENCED A FEW VERY SMALL BLISTERS. EMT DID NOT REQUIRE TREATMENT OR FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381264 | REGULATOR | CAN | INNOVO, INC | BT3125-R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |