FDA Adverse Event
Malfunction
Summary report: N
HUDSON AQAUAPAK WITH ADAPTOR 340 ML
MDR report key: 1854032
·
Received September 2, 2010
Report
- Report Number
- 1417411-2010-00031
- Event Type
- Malfunction
- Date Received
- September 2, 2010
- Date of Event
- August 24, 2010
- Report Date
- August 25, 2010
- Manufacturer
- TELEFELX MEDICAL
- Product Code
- BTT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THERE WILL BE NO SAMPLE RETURNED FOR INVESTIGATION. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE DEVICE IS LEAKING AT THE OXYGEN ADAPTOR WHEN THE O2 IS TURNED ON. THE DEVICE WAS BEING USED TO ADMINISTER AEROSOL THERAPY. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON AQAUAPAK WITH ADAPTOR 340 ML | AQUAPAK HUMIDIFIER | BTT | TELEFELX MEDICAL | NA | 02C1001289 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |