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 2020-01-23 for DIGITALDIAGNOST SINGLE DETECTOR 712020 manufactured by Philips Medical Systems Dmc Gmbh.
[181522125]
(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
[181522126]
The customer complained that the brake cylinder broke out of the frame of the patient support for stitching. The brake cylinder prevents the footboard of the patient support for stitching from falling down unexpected. . No injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768251-2020-00001 |
| MDR Report Key | 9621209 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-01-23 |
| 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 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIGITALDIAGNOST SINGLE DETECTOR |
| Generic Name | SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) |
| Product Code | MQB |
| Date Received | 2020-01-23 |
| Model Number | 712020 |
| Catalog Number | 712020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-01-23 |