FDA Adverse Event
Malfunction
Summary report: N
BOMIMED
MDR report key: 6708825
·
Received July 12, 2017
Report
- Report Number
- 3003213883-2017-00004
- Event Type
- Malfunction
- Date Received
- July 12, 2017
- Date of Event
- May 31, 2017
- Report Date
- July 5, 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
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED TO BOMIMED FOR EVALUATION.
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED TO BOMIMED FOR EVALUATION.
Description of Event or Problem · 1
LIGHT SOURCE FLICKERING NON-FUNCTIONAL AT TIME OF INTUBATION. REPORT STATES THE PATIENT CODED, BUT WAS STABILIZED WITH IMMEDIATE INTERVENTION. NO REPORTED INJURY.
Description of Event or Problem · 1
LIGHT SOURCE FLICKERING NON-FUNCTIONAL AT TIME OF INTUBATION. REPORT STATES THE PATIENT CODED, BUT WAS STABILIZED WITH IMMEDIATE INTERVENTION. NO REPORTED INJURY
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489094 | BOMIMED | LARYNGOSCOPE HANDLE | CCW | BOMIMED INC | OL-334L6 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |