FDA Adverse Event
Other
Summary report: N
ISO-GARD HEPA LIGHT
MDR report key: 576425
·
Received February 4, 2005
Report
- Report Number
- 2014730-2005-00001
- Event Type
- Other
- Date Received
- February 4, 2005
- Date of Event
- November 26, 2004
- Report Date
- February 4, 2005
- Manufacturer
- HUDSON RESPIRATORY CARE, INC., TELEFLEX MEDICAL
- Product Code
- BYD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 2004, AN ISO-GARD HEPA LIGHT FILTER HME HAD HIGH RESISTANCE ON A MECHANICALLY VENTILATED PT AFTER 1 TO 3 HOURS OF USE. THERE WAS NO REPORT OF MEDICAL INTERVENTION ON. THE INITIAL COMPLAINT. A MEDWATCH WAS RECEIVED IN 2005, THAT IDENTIFIED MEDICAL INTERVENTION TO PRECLUDE PT INJURY. THERE WAS NO ADVERSE EVENT OR PT INJURY REPORTED FROM THIS OCCURRENCE. THE FACILITY ALLEGED THAT THEY HAD OTHER HIGH RESISTANCE FILTERS; HOWEVER, THIS WAS THE ONLY ONE THAT REQUIRED MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISO-GARD HEPA LIGHT | FILTER | BYD | HUDSON RESPIRATORY CARE, INC., TELEFLEX MEDICAL | NA | ACTUAL UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |