FDA Adverse Event
Malfunction
Summary report: N
RESPIRATORY FORCE MEASURING
MDR report key: 431001
·
Received November 27, 2002
Report
- Report Number
- 2429473-2002-00213
- Event Type
- Malfunction
- Date Received
- November 27, 2002
- Report Date
- November 21, 2002
- Manufacturer
- RUSCH INC.
- Product Code
- BXR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTS THE OUT-OF BOX FAILURE OF DEVICE; DOES NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESPIRATORY FORCE MEASURING | RESPIRATORY - OXYGEN DELIVERY | BXR | RUSCH INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |