FDA Adverse Event
Malfunction
Summary report: N
AUTOVENT 4000 WITH CPAP
MDR report key: 1150885
·
Received August 27, 2008
Report
- Report Number
- 1924066-2008-00007
- Event Type
- Malfunction
- Date Received
- August 27, 2008
- Report Date
- August 26, 2008
- Manufacturer
- ALLIED HEALTHCARE PRODUCTS, INC.
- Product Code
- BTL
- PMA / PMN Number
- K070636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PROBLEM OCCURRED DURING CHECK OUT OF PRODUCT PRIOR TO USE ON PTS. THERE WAS NO REPORT OF ANY DEATH OR SERIOUS INJURY. UNITS ARE BEING RETURNED FOR EVAL, ROOT CAUSE ANALYSIS AND NEEDED CORRECTION, IF REQUIRED.
Description of Event or Problem · 1
CUSTOMER REPORTED PRODUCT FAILED TO FUNCTION AND/OR HAD INTERNAL LEAKAGE, DURING THE CHECK-OUT OF THE PRODUCT PRIOR TO USE ON PTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOVENT 4000 WITH CPAP | VENTILATOR | BTL | ALLIED HEALTHCARE PRODUCTS, INC. | L761CPAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |