FDA Adverse Event
Malfunction
Summary report: N
BOMIMED
MDR report key: 6708629
·
Received July 12, 2017
Report
- Report Number
- 3003213883-2017-00002
- Event Type
- Malfunction
- Date Received
- July 12, 2017
- Date of Event
- May 8, 2017
- Report Date
- June 22, 2017
- Manufacturer
- BOMIMED INC
- Product Code
- CCW
- Removal / Correction Number
- 9071838-07/13/17-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
BOMIMED IS IN THE MIDST OF ASSESSING WHAT IS CAUSING THE LIGHT TO RANDOMLY BE INTERMITTENT. NO CONCLUSIONS AS FURTHER TESTING IS REQUIRED.
Additional Manufacturer Narrative · 1
BOMIMED IS IN THE MIDST OF ASSESSING WHAT IS CAUSING THE LIGHT TO RANDOMLY BE INTERMITTEN. NO CONCLUSIONS AS FURTHER TESTING IS REQUIRED
Description of Event or Problem · 1
PUT NEW BATTERIES INTO LARYNGOSCOPE HANDLE, ATTACHED MAC 3 BLADE, CHECKED LIGHT AND WAS WORKING PROPERLY. BEGAN TO FLICKER DURING INTUBATION. INTUBATION WAS SUCCESSFUL EVEN WITH INTERMITTENT LIGHT.
Description of Event or Problem · 1
PUT NEW BATTERIES INTO LARYNGOSCOPE HANDLE, ATTACHED MAC 3 BLADE, CHECKED LIGHT AND WAS WORKING PROPERLY. BEGAN TO FLICKER DURING INTUBATION. INTUBATION WAS SUCCESSFUL EVEN WITH INTERMITTENT LIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490091 | BOMIMED | LARYNGOSCOPE HANDLE | CCW | BOMIMED INC | OL-334L6 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |