MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-27 for MAXTEC R129P02 manufactured by Maxtec.
[21987240]
Maxtec was informed by (b)(6) hosp that a dual air/oxygen hose supplied had inverted diss fittings. The faulty hose was used in ventilation during neonatal life flight transportation. (b)(6) hospital became aware of the problem when switching out the ventilator system. The hose was immediately removed from use and a pt risk assessment was performed. Per the hospital's initial review, there appeared to be no adverse events. Maxtec was informed by (b)(6) hosp of the occurrence. As the hose has been in use for treatment of high acuity pts, a detailed and thorough review was performed by the hosp's quality and risk mgmt team in checking pts documented saturations and vital signs. Following this review it has been confirmed that there were no adverse events. Per maxtec's investigation (b)(4) hoses were identified as suspect for this mfg error. Although standard respiratory treatment involves use of spo2 monitors, blood gas analysis, etc. , as part of pt care, a risk remains for pt harm, in particular with use of transport ventilators where gas analyzer/monitor alarms may not be part of the equipment configuration. Maxtec performed an immediate advisory notification for field review of the (b)(4) suspect hoses. Presently, (b)(4) of the (b)(4) suspect hoses have been confirmed correct. Review of all suspect hoses is in process. ((b)(4)).
Patient Sequence No: 1, Text Type: D, B5
[22202132]
Per maxtec's review of the hose on site at (b)(6) hosp, the diss fittings were confirmed to be inverted. The hose will be maintained by (b)(6) hosp and will be made available for further investigation as warranted. At this time, no other hose has been identified with the mfg error. It is believed that the incidence is isolated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722070-2012-00001 |
| MDR Report Key | 2895357 |
| Report Source | 06 |
| Date Received | 2012-11-27 |
| Date of Report | 2012-11-15 |
| Date Mfgr Received | 2012-11-09 |
| Date Added to Maude | 2013-03-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 6526 SOUTH COTTONWOOD ST. |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal | 84107 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXTEC |
| Generic Name | LOW PRESSURE VENTILATOR HOSE ACCESSORY |
| Product Code | CCL |
| Date Received | 2012-11-27 |
| Model Number | R129P02 |
| Catalog Number | R129P02 |
| Lot Number | 044693 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXTEC |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-27 |