FDA Adverse Event
Malfunction
Summary report: N
RUSCH RUSCH EQUIPLITE MTL DISP MAC 3
MDR report key: 4172795
·
Received October 10, 2014
Report
- Report Number
- 1044475-2014-00280
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- September 24, 2014
- Report Date
- September 25, 2014
- Manufacturer
- TELEFLEX
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT IS UNKNOWN IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE LIGHT WENT OUT DURING INTUBATION. NO PATIENT INJURY OR PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642591 | RUSCH RUSCH EQUIPLITE MTL DISP MAC 3 | LARYNGOSCOPE BLADE | BTR | TELEFLEX | 1401732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |