FDA Adverse Event
Malfunction
Summary report: N
HUDSON HUMID-VENT 2
MDR report key: 2163492
·
Received June 13, 2011
Report
- Report Number
- 8040412-2011-00086
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 23, 2011
- Report Date
- June 3, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 THE LARGE PORT ON THE FILTER WAS NOTICED TO BE OCCLUDED DURING USE ON A PT. COMPLAINT STATES THAT AFTER THE PT WAS INTUBATED; THE STAFF HAD PROBLEMS TRYING TO VENTILATE THE PT AND WHEN CHECKED; THE FILTER WAS NOTICED TO BE OCCLUDED. THE FILTER WAS CHANGED AND NO FURTHER ISSUES OCCURRED. PT CURRENT CONDITION IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON HUMID-VENT 2 | HEAT & MOISTER EXCHANGER | CAH | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |