FDA Adverse Event
Death
Summary report: N
GREEN RUSCH LITE LARYNGOSCOPE FIBER OPTIC BLADES, MACINTOSH
MDR report key: 2554442
·
Received April 26, 2012
Report
- Report Number
- 2554442
- Event Type
- Death
- Date Received
- April 26, 2012
- Date of Event
- April 25, 2012
- Report Date
- April 26, 2012
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CCW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
Narratives
Description of Event or Problem · 1
PATIENT IN SUDDEN CARDIAC/RESPIRATORY ARREST. CCP STATED INTUBATING ATTEMPTS WERE UNSUCCESSFUL.RELATED TO 'FAULTY' EQUIPMENT. METAL LARYNGOSCOPE HANDLE WITH DISPOSABLE BLADES: GEEN RUSCH SIZE 3 (MAC), REF#4043R, LOT #115131, PRODUCT # 004803300, GEEN RUSCH SIZE 3(MILLER), REF#4023, LOT# 0819231, PRODUCT# 004853300, GREEN RUSCH SIZE 2 (MILLER), REF# 4022, LOT# 0503001, AND PRODUCT# 004852200. PER CCP, ALL 3 BLADE LIGHTS WENT OUT DURING THE LIFTING STEP OF INTUBATION, AND/OR THE BLADE ACTUALLY BENT DOWNWARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREEN RUSCH LITE LARYNGOSCOPE FIBER OPTIC BLADES, MACINTOSH | BLADE, LARYNGOSCOPE | CCW | TELEFLEX MEDICAL | * | LOT #115131, LOT# 0819231,LOT# |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death |