MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-25 for VACUUM REGULATOR, PUSH TO SET, INTERMITTENT 1251 manufactured by Ohio Medical Llc.
[73576290]
Patient Sequence No: 1, Text Type: N, H10
[73576291]
Coming onto shift, was told patient had ng to low intermittent suction. When passing meds around 2000, was noticing the suction device on the wall was not intermittently suctioning, but was continuously suctioning. Wall device was set to intermittent suction. Md notified. The patient's ng was placed to gravity until orders for intermittent suction were received and new wall unit was placed and tested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6518058 |
| MDR Report Key | 6518058 |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-24 |
| Date of Event | 2017-04-21 |
| Report Date | 2017-04-24 |
| Date Reported to FDA | 2017-04-24 |
| Date Reported to Mfgr | 2017-04-24 |
| Date Added to Maude | 2017-04-25 |
| 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 |
| Brand Name | VACUUM REGULATOR, PUSH TO SET, INTERMITTENT |
| Generic Name | REGULATOR, VACUUM |
| Product Code | KDP |
| Date Received | 2017-04-25 |
| Model Number | 1251 |
| ID Number | JGGM21395 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL LLC |
| Manufacturer Address | 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-25 |