FDA Adverse Event
Other
Summary report: N
AMBU NEUROLINE 720
MDR report key: 2474076
·
Received February 24, 2012
Report
- Report Number
- 9610691-2012-00001
- Event Type
- Other
- Date Received
- February 24, 2012
- Report Date
- February 14, 2012
- Manufacturer
- AMBU A/S
- Product Code
- GXY
- PMA / PMN Number
- K970639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BACKING OF ELECTRODE WAS ACCIDENTLY LEFT IN A BABY'S CRIB AND THE BABY PUT THE PLASTIC BACKING IN HIS MOUTH AND CHOKED ON IT. THE NEUROLINE ELECTRODES ARE FOR PROFESSIONAL USERS ONLY.
Description of Event or Problem · 1
CUSTOMER WROTE: BACKING OF ELECTRODE IS A OPAQUE/WHITE PLASTIC. APPARENTLY ONE WAS ACCIDENTLY LEFT IN A BABY'S CRIB AND THE BABY PUT THE PLASTIC BACKING IN HIS MOUTH AND CHOKED ON IT. THE NURSE WAS ABLE TO REMOVE THE ITEM. PT WAS NOT HARMED. PT CONDITION WAS NOT AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMBU NEUROLINE 720 | SINGLE PATIENT SURFACE ELECTRODE | GXY | AMBU A/S | AMBU NEUROLINE 720 | 1359475 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |