FDA Adverse Event
Malfunction
Summary report: N
HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA
MDR report key: 3941880
·
Received June 3, 2014
Report
- Report Number
- 1044475-2014-00163
- Event Type
- Malfunction
- Date Received
- June 3, 2014
- Date of Event
- May 16, 2014
- Report Date
- May 16, 2014
- Manufacturer
- TELEFLEX
- Product Code
- BZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
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 (PHYSICIAN) ALLEGES THAT THE DEVICE WAS NOT MEASURING AN ACCURATE MEASUREMENT WHILE IN USE ON A PATIENT. THE BLUE INDICATOR WAS VERY LOOSE. THE DEVICE WAS CHANGED OUT FOR ANOTHER. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323453 | HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA | POCKET PEAK FLOW METER | BZH | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |