FDA Adverse Event
Malfunction
Summary report: N
HUDSON AQUAPAK W/040 ADAPTOR 640 SW
MDR report key: 2062365
·
Received March 18, 2011
Report
- Report Number
- 1417411-2011-00023
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 10, 2011
- Report Date
- February 23, 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 RESULTS OF THE EVAL ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE COMPLAINT ALLEGES THERE WERE O2 LEAKS DETECTED DURING THE CONNECTION. ANOTHER DEVICE WAS USED SUCCESSFULLY. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON AQUAPAK W/040 ADAPTOR 640 SW | AQUAPAK W/ ADAPTOR | CAF | TELEFELX MEDICAL | NA | 122106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |