MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-20 for TEE VALVED W/STEM AND PORT 15MM ID BASE 004050-A manufactured by Vyaire Medical, Inc.
[89832982]
It has been confirmed by (b)(4) that the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. If a sample or any additional information becomes available a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[89832983]
Customer reported that the part broke apart during patient use and a part lodged in the circuit causing the patient to have to be unhooked from the ventilator and put on a resuscitation bag. Customer does not have the broken part or the lot information. There was no physical damage caused to the circuit. The circuit was new on (b)(6) 2017 at 0315. When in the part lodged into the circuit the patient had high peak airway pressures and low volume. Rt and rn both bedside immediate response to bag the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00372 |
| MDR Report Key | 6965081 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-09-22 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-10-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA V NO.85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEE VALVED W/STEM AND PORT 15MM ID BASE |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2017-10-20 |
| Catalog Number | 004050-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO. 85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |