FDA Adverse Event
Injury
Summary report: N
ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON
MDR report key: 6725422
·
Received July 19, 2017
Report
- Report Number
- 3010838917-2017-00033
- Event Type
- Injury
- Date Received
- July 19, 2017
- Date of Event
- December 1, 2016
- Report Date
- July 19, 2017
- Manufacturer
- AOK TOOLING LIMITED
- Product Code
- CAI
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE COMPLAINT SAMPLE HAS NOT BEEN PROVIDED FOR EVALUATION AT THIS TIME. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, A FOLLOW-UP SUBMISSION WILL BE COMPLETED. (B)(4).
Description of Event or Problem · 1
UNDER INVESTIGATION. DISCONNECTION AND SLIPPING OUT AFTER 1 OR 2 MINUTES DURING PROCEDURE OF THE NEO VERSO CSC300 IN CONJUNCTION WITH Y FLOW SENSOR OF DRAEGER BABYLOG. NEITHER PATIENT INJURY NOR MEDICAL INTERVENTION HAS BEEN REPORTED. DEVICE SAMPLE AND LOT NUMBER ARE NOT AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE VENTILATOR ALARM ALERTED THE END-USER TO THE DISCONNECT CONDITION. THERE WAS NO REPORTED IMPACT TO THE PATIENT CLINICALLY. THE END-USER WAS ABLE TO STOP USE OF THE NEO-VERSO WITH THE DRAEGER BABYLOG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 506725 | ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) | CAI | AOK TOOLING LIMITED | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |