FDA Adverse Event
Malfunction
Summary report: N
RUSCH FOCS ILS MACINTOSH BLADE
MDR report key: 3788710
·
Received January 21, 2014
Report
- Report Number
- 1044475-2014-00014
- Event Type
- Malfunction
- Date Received
- January 21, 2014
- Date of Event
- December 1, 2013
- Report Date
- December 30, 2013
- Manufacturer
- TELEFLEX
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BLADE FAILED TO OPERATE CONSISTENTLY (LIGHT OPERATING INTERMITTENTLY) WHEN NEEDED FOR AN ICU PATIENT. THE SPECIFIC CONDITION OF THE PATIENT COULD NOT BE CONFIRMED FROM THE USER FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50997 | RUSCH FOCS ILS MACINTOSH BLADE | LARYNGOSCOPE BLADE | CCW | TELEFLEX | 084517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |