MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-27 for I.SERIES IB245 manufactured by Helmer, Inc..
| Report Number | 8739112 |
| MDR Report Key | 8739112 |
| Date Received | 2019-06-27 |
| Date of Report | 2019-06-07 |
| Date of Event | 2019-06-04 |
| Report Date | 2019-06-07 |
| Date Reported to FDA | 2019-06-07 |
| Date Reported to Mfgr | 2019-06-27 |
| Date Added to Maude | 2019-06-27 |
| 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 | I.SERIES |
| Generic Name | REFRIGERATOR, FREEZER, BLOOD STORAGE |
| Product Code | KSE |
| Date Received | 2019-06-27 |
| Model Number | IB245 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HELMER, INC. |
| Manufacturer Address | 14400 BERGEN BLVD NOBLESVILLE IN 46060 US 46060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-27 |