FDA Adverse Event
Malfunction
Summary report: N
HUDSON AQUAPAK 301 SW, 340 ML, INTL
MDR report key: 2241055
·
Received August 17, 2011
Report
- Report Number
- 1417411-2011-00090
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 1, 2011
- Report Date
- August 9, 2011
- Manufacturer
- TELEFELX MEDICAL
- Product Code
- CAF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT REPORTED AS: COMPLAINT ALLEGES THAT THERE WAS AN OXYGEN LEAK DURING TREATMENT. THE AIR APPEARED TO BE LEAKING THROUGH THE CONNECTOR THAT ATTACHES TO THE NASAL CANNULA. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON AQUAPAK 301 SW, 340 ML, INTL | NEBULIZER | CAF | TELEFELX MEDICAL | NA | 155117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |