MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for BREATHING PORTEX GENERAL ANESTHESIA ACCESSORIES manufactured by Smiths Medical Asd, Inc..
[128200346]
Information was received that a smiths medical breathing portex had an alarm sound about 24 hours after starting to use the product. Voltage was noted to be higher than 1. 4 and about 12 hours later, product was removed from patient. When product was checked, an e07 error message was issued. No patient injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-08342 |
| MDR Report Key | 8097648 |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-10-24 |
| Date Mfgr Received | 2018-10-25 |
| Date Added to Maude | 2018-11-21 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | AVENIDA CALIDAD #4 PARQUE INDUSTRIAL INTERNATIONA |
| Manufacturer City | TIJUANA, 22380 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREATHING PORTEX GENERAL ANESTHESIA ACCESSORIES |
| Generic Name | ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) |
| Product Code | OFP |
| Date Received | 2018-11-21 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-21 |