MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for EZ-IO POWER DRIVER 9058 manufactured by Teleflex Medical.
[114021847]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[114021848]
It was reported that the driver appeared to run out of battery however the indicator light had not turned red prior to this. It was green prior to the driver stopping working. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2018-00179 |
| MDR Report Key | 7681428 |
| Date Received | 2018-07-12 |
| Date of Report | 2018-06-19 |
| Date of Event | 2018-05-26 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2018-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EZ-IO POWER DRIVER |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2018-07-12 |
| Catalog Number | 9058 |
| Lot Number | G11026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-12 |