MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2010-09-17 for MAXTEC MAXVENTURI R211P03-004 manufactured by Maxtec.
[1426396]
A hospital located in (b)(6) reported the following incident to a (b)(4) rep (also located in (b)(4)) with respect to r21p03-004 - maxtec maxventuri air/oxygen mixer with a max-250e sensor medical device: "(b)(6) from (b)(6) hospital reported that oxygen reading is jumping to 100%. (b)(6) from the (b)(6) department informed me that the pt's sats dropped as a result of the maxventuri going from 100% to 21%. The 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 hospital notified the fph rep in (b)(4) that the pt died. The cause of death was unk at this time.
Patient Sequence No: 1, Text Type: D, B5
[8756907]
The maxventuri (b)(4) was received by maxtec on (b)(6) 2010 for investigation. The maxventuri was examined and no damage to the device was evident. In an effort to reproduce the fault described in the initial report, the unit was first tested at 40% oxygen and 40 lpm at 4 bar where the device performed as appropriate. Next the unit was occluded at the exit port and the reading increased to 99. 9% oxygen within 2 minutes and 47 seconds. The unit was set on static occlusion from 100% oxygen reading the unit was monitored to determine the time interval before the unit would drop to 21% oxygen. To further assist us in analysis, we requested specific details regarding the reported incident from (b)(6) hospital and investigation report from (b)(4), our distributor in (b)(4). Result: not fault was found with the returned maxventuri device. Based on performance test, the unit read 96. 7% oxygen at 2 minutes and 30 seconds. The oxygen reading was not found to drop to 21% unless it was turned off. It exhibited the well known "venturi effect". Additional info gathered from hospital and distributor concurred that the device did not malfunction. Conclusion: reported fault noted by hospital could not be replicated on the maxventuri device. The maxventuri passed both visual inspection and performance testing. Maxtec has not received complaints of any similar incidents with respect to this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722070-2010-00001 |
| MDR Report Key | 1845215 |
| Report Source | 06,08 |
| Date Received | 2010-09-17 |
| Date of Report | 2010-09-14 |
| Date of Event | 2010-08-05 |
| Date Facility Aware | 2010-08-05 |
| Report Date | 2010-09-14 |
| Date Reported to FDA | 2010-08-19 |
| Date Reported to Mfgr | 2010-08-17 |
| Date Mfgr Received | 2010-08-17 |
| Date Added to Maude | 2010-09-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TAMMY LAVERY |
| Manufacturer Street | 6526 SOUTH COTTONWOOD ST. |
| Manufacturer City | SALT LAKE CITY UT 84107 |
| Manufacturer Country | US |
| Manufacturer Postal | 84107 |
| Manufacturer Phone | 8013279870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXTEC MAXVENTURI |
| Generic Name | AIR/OXYGEN MIXER DEVICE / CODE CCL |
| Product Code | CCL |
| Date Received | 2010-09-17 |
| Returned To Mfg | 2010-08-20 |
| Model Number | MAXVENTURI |
| Catalog Number | R211P03-004 |
| Lot Number | UM69289 |
| ID Number | 999890101 FPH REF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXTEC |
| Manufacturer Address | 6526 SOUTH COTTONWOOD ST. SALT LAKE CITY UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-09-17 |