MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for FACE PLATE ASSEMBLY O-X-L VA-LAB- 100 UL manufactured by Amico Patient Care Corporation.
[126007428]
Pt came to the ed with suspected aspiration pneumonia. Pt was intubated and going to be transferred to the icu eventually. The staff was going to connect the pt to the wall oxygen and the oxygen flow meter bent forward. The pt desaturated and the staff had to retrieve an oxygen tank. The pt's heart rate slowed. The pt received cpr, epinephrine, and rosc was returned. After several days, the pt recovered and was discharged. The facilities tech replaced the face plate. The tech thinks that the inner piece of the plate was broken. The broken plate was not available to be assessed. The plate was inadvertently discarded by someone. The info in this report was obtained from a new face plate. The report is based off the premise that the broken face plate was made by the same mfr as the new face plate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080981 |
| MDR Report Key | 8028252 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-09-07 |
| Date Added to Maude | 2018-11-01 |
| 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 | 0 |
| Brand Name | FACE PLATE ASSEMBLY |
| Generic Name | FLOWMETER, TUBE, THORPE, BACK-PRESSURE |
| Product Code | CAX |
| Date Received | 2018-10-30 |
| Model Number | O-X-L VA-LAB- 100 UL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMICO PATIENT CARE CORPORATION |
| Manufacturer Address | 85 FULTON WAY RICHMOND HILL, ON L4B 2N4 CA L4B 2N4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-30 |