FDA Adverse Event
Malfunction
Summary report: N
HUDSON ADULT HEATED-WIRE CIRCUITS
MDR report key: 2102971
·
Received May 12, 2011
Report
- Report Number
- 3004365956-2011-00202
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- March 5, 2011
- Report Date
- April 20, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT DURING ASSEMBLY AND TESTING WITH INTENSIVE CARE VENTILATORS; THE CIRCUITS HAD LARGE RECURRENT LEAK FAILURES, AND APPEARED TO BE NO BONDING ON SEVERAL CONNECTED POINTS ON THE CIRCUITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON ADULT HEATED-WIRE CIRCUITS | HEATED-WIRE CIRCUITS | CAI | TELEFLEX MEDICAL | NA | 00086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |