FDA Adverse Event
Malfunction
Summary report: N
HUDSON POCKET PEAK, PEAK FLOW METER
MDR report key: 2945093
·
Received January 8, 2013
Report
- Report Number
- 1044475-2013-00005
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- November 1, 2012
- Report Date
- December 14, 2012
- Manufacturer
- TELEFLEX
- Product Code
- CAF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IT IS UNK IF THE DEVICE SAMPLE IS AVAILABLE FOR EVAL.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE PEAK FLOW METER READ A VALUE MUCH HIGHER THAT WAS NOT CLINICALLY POSSIBLE FOR THE PT'S CONDITION. ANOTHER DEVICE WAS USED TO DETERMINE THE PT'S PEAK FLOW. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10462 | HUDSON POCKET PEAK, PEAK FLOW METER | PEAK FLOW METER | CAF | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |