FDA Adverse Event
Malfunction
Summary report: N
HUDSON BREATHING CIRCUIT, NIV, ADULT
MDR report key: 2062435
·
Received March 18, 2011
Report
- Report Number
- 3004365956-2011-00104
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 22, 2011
- Report Date
- February 22, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BZO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE EXHALATION PORT CAP WILL NOT STAY IN PLACE. THE COMPLAINT STATES THAT THE CAP POPS OFF AT ALL FLOW AND PRESSURES. THE ALLEGED INCIDENT OCCURRED DURING A NON-INVASIVE VENTILATION TREATMENT TO A PATIENT. THE PORT CAP HAD TO BE RE-SECURED AND TAPED DOWN. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON BREATHING CIRCUIT, NIV, ADULT | BREATHING CIRCUIT | BZO | TELEFLEX MEDICAL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |