FDA Adverse Event
Malfunction
Summary report: N
HUDSON RCI
MDR report key: 19380639
·
Received May 23, 2024
Report
- Report Number
- 19380639
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- April 6, 2024
- Report Date
- May 2, 2024
- Manufacturer
- TELEFLEX, INC.
- Product Code
- BWF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE VOLUMETRIC EXERCISER DID NOT HAVE THE (MOUTHPIECE). LOT# 74J2300055.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1789334 | HUDSON RCI | SPIROMETER, THERAPEUTIC (INCENTIVE) | BWF | TELEFLEX, INC. | IPN049100 | 74J2300055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |