FDA Adverse Event
Malfunction
Summary report: N
PRECISION FLOW
MDR report key: 4273184
·
Received October 16, 2014
Report
- Report Number
- 4273184
- Event Type
- Malfunction
- Date Received
- October 16, 2014
- Date of Event
- October 9, 2014
- Report Date
- October 16, 2014
- Manufacturer
- VAPOTHERM, INC
- Product Code
- BTT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
DURING HIGH FLOW HUMIDIFICATION THE GAS FLOW KEPT STARTING AND STOPPING. THE THERAPIST COULD NOT CORRECT THIS ISSUE. THE DEVICE WAS EXCHANGED WITH ANOTHER UNIT AND THERAPY CONTINUED WITH NO ISSUES. THIS IS SECOND EVENT OF THIS TYPE ON THIS DEVICE. A CLINICIAN STATED THAT A NEW CANNULA IS IN USE AND MAY BE CONTRIBUTING TO FLOW ERRORS. BIOMEDICAL ENGINEERING (BME) RETRIEVED BOTH THE DEVICE AND CANNULA TO SEND TO THE MANUFACTURER FOR ANALYSIS.======================MANUFACTURER RESPONSE FOR HIGH FLOW HUMIFIFIER, VAPOTHERM (PER SITE REPORTER).======================DEVICE TO BE RETURNED FOR REPAIR AND EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 657135 | PRECISION FLOW | HUMIDIFIER, RESPIRATORY GAS (DIRECT PATIENT INTERFACE) | BTT | VAPOTHERM, INC | * | * | |
| 657362 | COMFORT SOFTPLUS | CANNULA, NASAL, OXYGEN | CAT | VAPOTHERM, INC | * | 07292014N42 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR |