MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-03-16 for PRISM 2000 453566512911 NA manufactured by Philips Medical Systems(cleveland), Inc..
[745717]
Info has been taken from mdr fileld by site. "event desc: pt was scheduled for a bone scan in nuclear medicine. Nuclear medicine technologist set up a whole body automatic contour to achieve the best resolution. Pt contact alarm went off during the test. Technologist tried to bring head 1 up because it had not followed the contour, but it would not respond. Technologist moved head 2 away and lowered the table to remove the pt. All protocols and policies were followed. Fail-safe devices on the scanner functioned as expected. No pt injury. Service engineer was called the next day. Encoder was recalibrated and put back into service. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do" philips medical systems was made aware of this issue on 2/27/07, when a copy of the mdr filed by the site was received.
Patient Sequence No: 1, Text Type: D, B5
[8090445]
Investigation determined that head 1 was at it's outer limit. Power was cycled and the head was able to be moved. Gantry ring cable was determined to be have an open signal wire and was replaced. The encoder was determined to be off by 4cm. Field service recalibrated the encoder on the system. System was operating as intended once cable was replaced and encoder was recalibrated. Collision circuitry worked as designed. There was no serious injury to pt or operator. Engineering determined that based on corrections made to the system, the most probable root cause was a broken signal wire in the gantry ring cable assembly, which would have prevented the technologist from being able to retract head 1 once pt contact was made. A contributing factor was that the encoder was out of calibration.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2007-00003 |
| MDR Report Key | 979682 |
| Report Source | 00 |
| Date Received | 2007-03-16 |
| Date of Report | 2007-03-16 |
| Date of Event | 2006-11-07 |
| Date Facility Aware | 2006-11-07 |
| Date Mfgr Received | 2007-02-27 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 2008-01-16 |
| 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 | MELINDA NOVATNY |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404834255 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM 2000 |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IYX |
| Date Received | 2007-03-16 |
| Model Number | 453566512911 |
| Catalog Number | NA |
| Lot Number | EQUIP#205991 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 947522 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| Manufacturer Address | 595 MINER RD. CLEVELAND OH 44143 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-16 |