MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-26 for ISU MODEL 6-1251 manufactured by Ohmeda Medical.
[76034220]
Patient Sequence No: 1, Text Type: N, H10
[76034221]
The regulator did not worked in code. Portable suction used while second setup was completed during code. Maintenance came to (room of code) and checked headwall suction. Found to be working properly. Maintenance said that pressures at the wall checked ok. Took regulator and tested it in room. Plugged in, and turned pressure knob to "on" and ran pressure up through entire range to "high" and back down. Passed operational check. Returned gauge to nurse manager.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6593537 |
| MDR Report Key | 6593537 |
| Date Received | 2017-05-26 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-05-18 |
| Report Date | 2017-05-24 |
| Date Reported to FDA | 2017-05-24 |
| Date Reported to Mfgr | 2017-05-24 |
| Date Added to Maude | 2017-05-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISU MODEL |
| Generic Name | SUCTION REGULATOR |
| Product Code | KDP |
| Date Received | 2017-05-26 |
| Model Number | 6-1251 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHMEDA MEDICAL |
| Manufacturer Address | 8880 GORMAN RD. LAUREL MD 20723 US 20723 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-05-26 |