MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-06 for PRISM 2000XP manufactured by Philips Medical Systems (cleveland), Inc..
[44568581]
Patient Sequence No: 1, Text Type: N, H10
[44568582]
Upon daily quality check, camera malfunctioned. Unable to run automatic programs or movements without camera malfunction.
Patient Sequence No: 1, Text Type: D, B5
[55276428]
Patient Sequence No: 1, Text Type: N, H10
[55276429]
Upon daily quality check, camera malfunctioned- the date and time did not correspond to the actual date and time. The date and time was 23 hours behind actual time. The device is approximately 10 years old. Unable to run automatic programs or movements without camera malfunction. Biomed logged in to service mode. They added the correct date and time, validated the device, and the camera was returned to service. It was determined that this issue occurred on the first of every month. The next month, no errors were found when the camera was validated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5636580 |
| MDR Report Key | 5636580 |
| Date Received | 2016-05-06 |
| Date of Report | 2016-04-08 |
| Date of Event | 2016-04-05 |
| Report Date | 2016-04-05 |
| Date Reported to FDA | 2016-04-05 |
| Date Reported to Mfgr | 2016-04-05 |
| Date Added to Maude | 2016-05-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | PRISM 2000XP |
| Generic Name | CAMERA, SCINTILLATION (GAMMA) |
| Product Code | IYX |
| Date Received | 2016-05-06 |
| Model Number | PRISM 2000XP |
| ID Number | CE#3409 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Address | 595 MINER RD CLEVELAND OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-06 |