FDA Adverse Event
Malfunction
Summary report: N
HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA
MDR report key: 3815848
·
Received March 25, 2014
Report
- Report Number
- 1044475-2014-00075
- Event Type
- Malfunction
- Date Received
- March 25, 2014
- Date of Event
- March 6, 2014
- Report Date
- March 12, 2014
- Manufacturer
- TELEFLEX
- Product Code
- BZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT WHEN THE PT BLOWS INTO THE PEAK FLOW METER THE BLUE INDICATOR MOVES VERY EASILY. THE PT BARELY BREATHES IN TO THE METER AND THE BLUE INDICATOR MOVES TO THE HIGH END OF THE SCALE WITH VERY LITTLE PRESSURE. THE DEVICE WAS CHANGED OUT FOR ANOTHER ONE. NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175238 | HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA | PEAK FLOW METER (SPIROMETRY | BZH | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |