FDA Adverse Event
Other
Summary report: N
DISPOSABLE LARYNGOSCOPE SYSTEM
MDR report key: 38435
·
Received September 5, 1996
Report
- Report Number
- 2020364-1996-00001
- Event Type
- Other
- Date Received
- September 5, 1996
- Date of Event
- July 25, 1996
- Report Date
- September 4, 1996
- Manufacturer
- ANESTHESIA MEDICAL SPECIALTIES
- Product Code
- EQN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NOTE: ALL OF THE INFO CONTAINED IN SECTION F WAS PROVIDED BY THE MFR.
Description of Event or Problem · 1
THE LARYNGOSCOPE BLADE, (SIZE UNREPORTED) BROKE, NEAR THE CONTACT POINT, DURING AN INTUBATION ATTEMPT. THE INTUBATION WAS BEING PERFORMED IN THE EMERGENCY ROOM. A 42 YR OLD MALE PT, WEIGHING APPROX. 300 LBS, WAS IN COMPLETE CARDIO-PULMINARY ARREST. INTUBATION WAS SUCCESSFUL ON THE SECOND ATTEMPT, USING A REUSABLE BLADE (SIZE UNREPORTED). THE PT HAD A BULL NECK. THE PT'S VITAL SIGNS WERE NOT RESTORED. "I DO NOT BELIEVE TECHNIQUE WAS A (FACTOR); I HAVE SUCCESSFULLY PERFOMED 1500 INTUBATIONS", STATED EMERGENCY ROOM PHYSICIAN. THE BLADE WAS NOT SAVED. THERE WAS NO CAUSAL CONNECTION BETWEEN THE BLADE BREAKING AND THE PT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE LARYNGOSCOPE SYSTEM | LARYNGOSCOPE BLADE, DISPOSABLE | EQN | ANESTHESIA MEDICAL SPECIALTIES | MACINTOSH, SIZE UNKNOWN | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 * | Other |