MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-03-28 for PRISM 1000 210337 NA manufactured by Philips Medical Systems (cleveland), Inc..
[603104]
During a cardiac study the patient moved and bumped into the detector. The collision circuitry operated as expected and motion was halted. When the scan was resumed, the detector head failed to follow its planned orbit and made contact with the table. The technologist hit the override button which did not stop the detector. The detector stopped when the e-stop button was pressed by the technologist. No patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[7958308]
Investigation determined that the issue occurred as a result of a series of events; initial patient/detector contact occurred at a point in the scan where the detector was not moving in or out, the detector failed to follow its planned orbit when scan resumed, the technologist did not monitor the patient during the scan and failed to notice the detector moving out of its planned orbit when the detector made contact with the table. Evaluation of parts by service determined that the collision circuitry and e-stop were operating as intended. The override button is not intended to half motion, and when the e-stop was pressed, the detector stopped. Table top and collision pad were replaced. Software evaluation by engineering determined that when a collision occurs during a point in the scan where there is no in or out movement, the detector will not follow its planned orbit when the scan resumes. Further evaluation determined that the less sensitive rolled edge of the detector made contact with the table, which did not activate collision circuitry. A review of the complaint files determined that no other complaints were found regarding this type of issue. The technologist was not monitoring the patient during the scan, per instructions. Technologist will be retrained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2007-00004 |
| MDR Report Key | 833213 |
| Report Source | 07 |
| Date Received | 2007-03-28 |
| Date of Report | 2007-03-28 |
| Date of Event | 2007-02-28 |
| Date Mfgr Received | 2007-02-28 |
| Device Manufacturer Date | 1994-06-01 |
| Date Added to Maude | 2007-04-03 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MELINDA NOVATNY |
| Manufacturer Street | 595 MINER ROAD |
| 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 1000 |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IYX |
| Date Received | 2007-03-28 |
| Model Number | 210337 |
| Catalog Number | NA |
| Lot Number | 72801 |
| 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 | 820521 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Address | 595 MINER RD. CLEVELAND OH 44143 US |
| Baseline Brand Name | PRISM 1000 |
| Baseline Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Baseline Model No | 210337 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-28 |