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 2020-03-27 for BRILLIANCE AIR 40/64/UCT 728231 manufactured by Philips Medical Systems (cleveland), Inc..
[188257235]
Reporting determination: this complaint has been evaluated based on the information provided; there is no allegation of death or serious injury. The issue reported was that the couch had descended to its lowest limit uncommanded with a patient on it. The couch was about one meter off the ground when this occurred. The patient left the ct department with a complaint of back pain and was pending a doctor assessment. Based on the available information, this issue has been initially determined to be a reportable event. Therefore, this complaint is considered to be a reportable event to the regulatory agency per ha198-004-00 adverse event reporting procedure (ct/nm). This issue is not a reportable radiation event per ha198-005-00 ct/ami radiation event reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525965-2020-01000 |
| MDR Report Key | 9887862 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Event | 2020-03-02 |
| Date Facility Aware | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-27 |
| 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 AIR 40/64/UCT |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
| Product Code | JAK |
| Date Received | 2020-03-27 |
| Model Number | 728231 |
| Catalog Number | 728231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-27 |