MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-12 for NIM CONTACT 8229508 manufactured by Medtronic Xomed, Inc..
[94504620]
Patient Sequence No: 1, Text Type: N, H10
[94504621]
Patient was brought to the operating room and readied for intubation. Patient was intubated by doctor using the nim contact emg endotracheal tube (ett) size 8 without problem. When the doctor went to inflate the ett cuff, the inflation tubing came off in his hand and he was unable to inflate the cuff. The doctor then utilized an introducer (bougie) and removed the defective ett, and replaced it with another nim contact emg ett size 8. The cuff was easily inflated and the case proceeded without further problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7107922 |
| MDR Report Key | 7107922 |
| Date Received | 2017-12-12 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-09-28 |
| Report Date | 2017-11-02 |
| Date Reported to FDA | 2017-11-02 |
| Date Reported to Mfgr | 2017-11-02 |
| Date Added to Maude | 2017-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM CONTACT |
| Generic Name | STIMULATOR, NERVE |
| Product Code | BXN |
| Date Received | 2017-12-12 |
| Model Number | 8229508 |
| Catalog Number | 8229508 |
| Lot Number | 0210050657 |
| ID Number | M000030B585 A 0079 |
| Device Expiration Date | 2019-08-25 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JAX FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-12 |