MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-19 for ORS HUSH SLUSH SYSTEM ORS-1075HS manufactured by Microtek Medical, Inc..
[114429849]
Transplant case required the ecolab hush slush machine for patient use. Machine did not make it to the patient because the machine would not work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7702162 |
| MDR Report Key | 7702162 |
| Date Received | 2018-07-19 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-07-04 |
| Report Date | 2018-07-13 |
| Date Reported to FDA | 2018-07-13 |
| Date Reported to Mfgr | 2018-07-19 |
| Date Added to Maude | 2018-07-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | ORS HUSH SLUSH SYSTEM |
| Generic Name | WARMER, IRRIGATION SOLUTION |
| Product Code | LHC |
| Date Received | 2018-07-19 |
| Model Number | ORS-1075HS |
| Device Availability | * |
| Device Age | 16 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK MEDICAL, INC. |
| Manufacturer Address | 13000 DEERFIELD PARKWAY SUITE 300 ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-19 |