FDA Adverse Event
Malfunction
Summary report: N
HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL
MDR report key: 3837830
·
Received April 8, 2014
Report
- Report Number
- 1044475-2014-00114
- Event Type
- Malfunction
- Date Received
- April 8, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 3, 2014
- Manufacturer
- TELEFLEX
- Product Code
- BZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE PEAK FLOW METER IS GIVING AN INACCURATE READING. ANOTHER DEVICE WAS USED ON THE PT. THE PT'S CONDITION IS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210228 | HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL | PEAK FLOW METER | BZH | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |