MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-08-19 for MAXTEC MAXVENTURI MEDICAL OXYGEN SENSOR AND MAXTEC MAXVENTURI R211P03-004 manufactured by Maxtec Inc.
[19753950]
(b)(4). The (b)(4) maxtec maxventuri medical oxygen sensor and the maxtec maxventuri associated with this reported incident were mfg by (b)(4) and are being distributed by (b)(4). These products are not distributed by fph in the usa. However, these products are being promoted by fph's sales team in the usa. Fph has advised (b)(4) of this reported incident. We are working to provide any support required for their investigation. (b)(4) will provide their investigation results directly to fda. Fph has not received complaints of any similar incidents for these particular products.
Patient Sequence No: 1, Text Type: N, H10
[19846999]
A hosp in (b)(6) reported the following to a fisher and paykel healthcare (fph) rep in (b)(4) involving an (b)(4) maxtec maxventuri medical oxygen sensor and a maxtec maxventuri: "(b)(6) from (b)(6) reported that oxygen reading is jumping to 100%. (b)(6) from (b)(6) informed me that the pt's sats dropped as a result of the max venturi going from 100% oxygen to 21%. The medical staff did everything they could to bring the oxygen concentration back up but this failed and the pt suffered as a result. " on (b)(6) 2010, the hosp notified the fph rep in (b)(4) that the pt died. The cause of death is unk at this stage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2010-00493 |
| MDR Report Key | 1813619 |
| Report Source | 99 |
| Date Received | 2010-08-19 |
| Date of Report | 2010-08-05 |
| Date Facility Aware | 2010-08-05 |
| Report Date | 2010-08-17 |
| Date Reported to FDA | 2010-08-19 |
| Date Reported to Mfgr | 2010-08-17 |
| Date Added to Maude | 2011-01-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXTEC MAXVENTURI MEDICAL OXYGEN SENSOR AND MAXTEC MAXVENTURI |
| Generic Name | UNK |
| Product Code | CCL |
| Date Received | 2010-08-19 |
| Returned To Mfg | 2010-08-16 |
| Model Number | R211P03-004 |
| Catalog Number | R211P03-004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXTEC INC |
| Manufacturer Address | 6526 S COTTONWOOD ST SALT LAKE CITY UT 84107 US 84107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-08-19 |