MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-10 for ISU 1251 manufactured by Ohio Medical Corporation.
[44792259]
Patient Sequence No: 1, Text Type: N, H10
[44792260]
The vacuum regulator comes loose from wall outlet. At times the regulator leans forward compromising suction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5642878 |
| MDR Report Key | 5642878 |
| Date Received | 2016-05-10 |
| Date of Report | 2016-04-25 |
| Date of Event | 2016-02-05 |
| Report Date | 2016-04-25 |
| Date Reported to FDA | 2016-04-25 |
| Date Reported to Mfgr | 2016-04-25 |
| Date Added to Maude | 2016-05-10 |
| 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 |
| Generic Name | REGULATOR, VACUUM |
| Product Code | KDP |
| Date Received | 2016-05-10 |
| Model Number | ISU 1251 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | 1111 LAKESIDE DR. GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-10 |