MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for TELLIGENCE manufactured by Ascom (us) Inc..
[122798766]
Call bell system failed in unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7937726 |
| MDR Report Key | 7937726 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-07-05 |
| Report Date | 2018-09-28 |
| Date Reported to FDA | 2018-09-28 |
| Date Reported to Mfgr | 2018-10-05 |
| Date Added to Maude | 2018-10-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | TELLIGENCE |
| Generic Name | SYSTEM, ENVIRONMENTAL CONTROL, POWERED |
| Product Code | IQA |
| Date Received | 2018-10-05 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCOM (US) INC. |
| Manufacturer Address | 9024 TOWN CENTER PARKWAY BRADENTON FL 34202 US 34202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-05 |