MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-09 for MOBILEDIAGNOST WDR REL. 2 712002 manufactured by .
[132563424]
The investigation is still ongoing on this event. When the investigation is completed a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[132564305]
Customer (hospital) reported death of neonatal baby which they allege is due to poor imaging of tubes and lines, resulting in line touching heart and causing af until death occurred. Customer alleged that image was not good enough quality to see tip of line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-2019-00001 |
| MDR Report Key | 8232632 |
| Date Received | 2019-01-09 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-12-14 |
| Date Facility Aware | 2018-12-18 |
| Report Date | 2018-12-18 |
| Date Reported to Mfgr | 2018-12-18 |
| Date Added to Maude | 2019-01-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | MOBILEDIAGNOST WDR REL. 2 |
| Generic Name | SYSTEM, X RAY, MOBILE |
| Product Code | IZL |
| Date Received | 2019-01-09 |
| Model Number | 712002 |
| Catalog Number | 712002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-01-09 |