MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-10 for BRILLIANCE BRILLIANCE 64 UPGRADES 728231 manufactured by Philips Medical Systems (cleveland), Inc..
[183387348]
We have not completed our investigation of this event. We will file a followup emdr at the completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183387349]
This complaint has been evaluated based on the information provided. The issue reported was that the customer finger was pinched and broken while operating the couch horizontally. Based on the available information, this issue has been determined to be a reportable event. Therefore, this complaint is considered to be a reportable event to the regulatory agency per (b)(4) adverse event reporting procedure (ct/nm). This issue is not a reportable radiation event per (b)(4) ct/ami radiation event reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003768277-2020-01002 |
| MDR Report Key | 9811480 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Event | 2020-01-21 |
| Date Facility Aware | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-03-10 |
| 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. DERRICK MASSURI |
| Manufacturer Street | 595 MINER ROAD |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Street | 595 MINER ROAD |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRILLIANCE |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-03-10 |
| Model Number | BRILLIANCE 64 UPGRADES |
| Catalog Number | 728231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Address | 595 MINER ROAD CLEVELAND OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |