MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-02 for PRISM 2000XP 453566512911 manufactured by Philips Medical Systems (cleveland), Inc..
[1158139]
When the operator released the buttons on the hand controller of a prism system during a study, the detector did not stop moving until the operator pressed the e-stop button. The pinhole collimator which was mounted onto detector 1 made contact with the patient. The operator raised detector 1 and continued the scan. No injury to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
[8145142]
We have confirmed that the pinhole collimator can come in contact with a patient. If the override is cleared when a manual motion is active, that manual motion will complete a move to the minimum or maximum limit regardless of patient position. A warning statement is provided in the user manual and on a label on the pinhole collimator stating that the collimator is not provided with collision sensors and that the operator must exercise caution when moving the gantry to avoid making contact with the patient. Additionally, e-stop buttons are available for the operator to halt all system motion if contact appears imminent. Note: another related issue (pinhole collimator coming into contact with a patient) was reported to fda under mdr #1525965-2006-00007. No correction was required. The issue was determined to be due to operator error. Internal cross
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2009-00009 |
| MDR Report Key | 1381265 |
| Report Source | 07 |
| Date Received | 2009-03-02 |
| Date of Report | 2009-03-02 |
| Date of Event | 2009-01-29 |
| Date Mfgr Received | 2009-02-02 |
| Date Added to Maude | 2009-08-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERT PHILLIPS, SR. DIRECTOR |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404833000 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM 2000XP |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IYX |
| Date Received | 2009-03-02 |
| Model Number | 453566512911 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-03-02 |