MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-24 for 4005H manufactured by Ethox Medical, Llc. (sunmed).
[90085573]
Patient Sequence No: 1, Text Type: N, H10
[90085574]
A 500ml pressure bag gauges not working properly. Anesthesia tech, in preparation to set up the operating rooms, have found that the needle on the gauge works sporadically when pumping up the bag and the needle does not move to green. This has happened 4-5 times over the past week with the same lot # and 6 have been pulled from the shelf. One that was pulled from the shelf was opened and did the same thing, needle on the gauge not moving when the bag is being inflated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6971969 |
| MDR Report Key | 6971969 |
| Date Received | 2017-10-24 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-10-10 |
| Report Date | 2017-10-11 |
| Date Reported to FDA | 2017-10-11 |
| Date Reported to Mfgr | 2017-10-11 |
| Date Added to Maude | 2017-10-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-10-24 |
| Model Number | 4005H |
| Catalog Number | 4005H |
| Lot Number | 170300149 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHOX MEDICAL, LLC. (SUNMED) |
| Manufacturer Address | 2710 NORTHRIDGE DR NW STE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-24 |