MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for AMICO SCOUT SUCTION REGULATOR SCOUT SRA-PI manufactured by Amico Patient Care Corporation.
[112312711]
Diss quick connect system on scout model vacuum regulator failed to prevent an accidental connection to an amico o2 gas outlet. Mfr stated they found a tolerance issue with index pin on the regulator wall connector (chemtronics style). Problem only occurred when used with amico o2 wall outlet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078024 |
| MDR Report Key | 7633753 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-06-07 |
| Date Added to Maude | 2018-06-25 |
| 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 | AMICO SCOUT SUCTION REGULATOR |
| Generic Name | REGULATOR, VACUUM |
| Product Code | KDP |
| Date Received | 2018-06-22 |
| Model Number | SCOUT SRA-PI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMICO PATIENT CARE CORPORATION |
| Manufacturer Address | ONTARIO, RICHMAN HILL L4B 1G6 CA L4B 1G6 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-22 |