MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for OXYGEN HIGH PRESSURE HOSE 81-3311-06 manufactured by Precision Medical, Inc..
[182328111]
New oxygen high pressure hose was found to be not patent upon first use. Hose was attached to an air / o2 blender. Blender was placed in use in our nicu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093504 |
| MDR Report Key | 9785945 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-26 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | OXYGEN HIGH PRESSURE HOSE |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-28 |
| Model Number | 81-3311-06 |
| Lot Number | 1913813-0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |