FDA Adverse Event
Malfunction
Summary report: N
HUDSON INCENTIVE SPIROMETER, INTL.
MDR report key: 2160900
·
Received June 16, 2011
Report
- Report Number
- 3004365956-2011-00244
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 30, 2011
- Report Date
- June 7, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BWF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE PT'S RELATIVE INFORMED THE STAFF THAT THE INCENTIVE SPIROMETER THAT WAS GIVEN TO HER RELATIVE SEEMED TO BE BROKEN. ON EXAMINATION, THE MOUTHPIECE OF THE INCENTIVE SPIROMETER WAS CRACKED. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON INCENTIVE SPIROMETER, INTL. | INCENTIVE SPIROMETER | BWF | TELEFLEX MEDICAL | NA | 02E1002809 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |