MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for UNKNOWN manufactured by Ohmeda Medical.
[140149538]
Oxygen wall port leaking. Maintenance turned off o2 and was unable to fix. Pt was requiring oxygen so was moved to another room. Mother was unhappy regarding the move but was understanding. Room out of service until repair takes place. Note: no identifiers are available from the wall plate itself. Maintenance had the unit repaired in 24 hrs. Many of the wall ports are "wiggly", mainly due to age of the unit and the installation process unable to locate sn, model #, or other identifier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8458950 |
| MDR Report Key | 8458950 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-01-29 |
| Report Date | 2019-03-11 |
| Date Reported to FDA | 2019-03-11 |
| Date Reported to Mfgr | 2019-03-28 |
| Date Added to Maude | 2019-03-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | UNKNOWN |
| Generic Name | REGULATOR, PRESSURE, GAS CYLINDER |
| Product Code | CAN |
| Date Received | 2019-03-28 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | OHMEDA MEDICAL |
| Manufacturer Address | 3030 OHMEDA DRIVE MADISON WI 53718 US 53718 |
| Brand Name | UNKNOWN |
| Generic Name | REGULATOR, PRESSURE, GAS CYLINDER |
| Product Code | CAN |
| Date Received | 2019-03-28 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHMEDA MEDICAL |
| Manufacturer Address | 3030 OHMEDA DRIVE MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |