MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-24 for PSI-TEC III ASPIRATOR, 110V PT-ASP-III-110 manufactured by Mentor Texas.
[114940107]
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made. As such, the investigation will be closed. If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate. Since no lot number was provided, no device history record (dhr) review could be performed. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[114940108]
It was reported that a (b)(6) old caucasian patient underwent a procedure with a 110v psi-tec iii aspirator. After the patient had been placed under general anesthesia, the aspirator would not start. This resulted in a 30-minute procedural delay, which required having to borrow a machine from another hospital in order to continue the procedure. The patient? S last known condition was fully recovered with no residual effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2018-04488 |
| MDR Report Key | 7716489 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-24 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-06-27 |
| Date Added to Maude | 2018-07-24 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 3041 SKYWAY CIRCLE NORTH |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal | 75038 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | MENTOR TEXAS |
| Manufacturer Street | 3041 SKYWAY CIRCLE NORTH |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSI-TEC III ASPIRATOR, 110V |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2018-07-24 |
| Catalog Number | PT-ASP-III-110 |
| Lot Number | 04181804 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR TEXAS |
| Manufacturer Address | 3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-24 |