MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-21 for DIGITALDIAGNOST 4.1 HIGH PERFORMANCE 712031 manufactured by Philips Medical Systems Dmc Gmbh.
[136760574]
(b)(4). 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
[136760575]
The customer complained that the plastic clip of patient support for stitching slipped out of position and the foot board dropped down and hit the foot of operator. Operator suffered a fracture of one big toe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768251-2019-00003 |
| MDR Report Key | 8358245 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-11 |
| Date of Event | 2019-02-08 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. DUSTY LEPPERT |
| Manufacturer Street | ROENTGENSTR. 24 |
| Manufacturer City | HAMBURG 22335 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22335 |
| Manufacturer Phone | 405078-229 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2843-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIGITALDIAGNOST 4.1 HIGH PERFORMANCE |
| Generic Name | SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) |
| Product Code | MQB |
| Date Received | 2019-02-21 |
| Model Number | 712031 |
| Catalog Number | 712031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| Manufacturer Address | ROENTGENSTR. 24 HAMBURG 22335 GM 22335 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-21 |