MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-12 for PRISM NUCLEAR GAMMA CAMERA SYSTEM N215003 88201 manufactured by Philips Medical Systems (cleveland), Inc..
[31180844]
(b)(4). On (b)(6) 2014, the customer reported that their prism 2000's gamma camera was acquiring a left and right lateral static views when unexpectedly the heads began to radius in without user intervention. The heads collided with the patient table. The technologist stopped the motions by removing power to the gantry through the main power button. The technologist retracted the heads after power up of the system without any errors and removed the patient from the table in a controlled manner. The philips field service engineer (fse) confirmed that there was no harm to the patient, operator, or bystander. The patient was moved to another camera within the department for a rescan. The camera was taken out of service and the philips help desk was notified to dispatch an fse for investigation. The trained operator's attempts to use the manual e-stop were unsuccessful. However, it is unknown if the operator attempted to use the e-stop after the power was shut off. On (b)(6) 2014, the fse arrived on site and evaluated the system. The fse confirmed that after the power cycle, all manual e-stop and collision detection circuitry for collimator faces were tested and proved to be operating. Therefore, it cannot be determined if the e-stop failed or if the collision detection circuitry on the collimator face failed to initiate an e-stop when the detectors encountered the patient pallet. Upon inspection, the fse noted the foot table pedestal was loose from the floor, which was due to the collision with the patient table. The detector 2 crystal was broken and lehr collimators on both detectors were damaged due to the collision with the patient table. There were no stuck buttons. The fse notified the user that the camera was to remain out of clinical use until parts could be replaced. The fse later confirmed that the camera needed to be decommissioned because of no availability of parts due to the camera being at end of life (eol) status. It was dismantled and removed from hospital on (b)(6) 2014. Per the prism ifu, quality control measures should be conducted prior to using the prism camera. On (b)(6) 2014 preventive maintenance for prism gamma camera and detector calibration was performed. Daily qc calibration was performed to verify uniformity of detectors and that it was within manufactured specifications. Further investigation by engineering was unable to be performed due to the logfiles not being available for analysis. No parts were returned for evaluation. In addition, the major components like the detector crystal and collimator have no availability due to the prism 2000's camera systems being eol. The camera was decommissioned and a cause undetermined due to a lack of information. Since there were no parts returned from the field or log files provided, a cause of the issue could not be determined by engineering. The mitigation's for this issue include: routine inspection through service pm and/or customer pm documentation. Reflecting required inspection of mechanics and hardware limits. Service and operator documentation reflecting detailed corrective actions for specific radius motion failure modes. Install warning labels on service override switches and system covers reflecting only qualified service personnel should remove equipment covers and perform maintenance, repairs or any corrective measures. The camera was decommissioned because of no availability of parts due to the camera being at end of life (eol) status. It was dismantled and removed from the hospital on (b)(6)2014.
Patient Sequence No: 1, Text Type: N, H10
[31180905]
The customer reported that their prism 2000's gamma camera was acquiring a left and right lateral static views when unexpectedly, the heads began to radius in without user intervention. The heads collided with the patient table. The technologist stopped the motions by removing power to the gantry through the main power button. She retracted the heads after power up of the system without any errors and removed the patient from the table in a controlled manner. The trained operator's attempts to use the manual e-stops were unsuccessful. Collision detection circuitry on the collimator face failed to initiate an e-stop when the detectors encountered the patient pallet. The philips field service engineer (fse) confirmed that there was no harm to the patient, operator, or bystander. The patient was moved to another camera within the department for a rescan. The camera was taken out of service and the local help desk was notified to dispatch an fse for investigation. The powering off of the system eliminated all logs of the event, thus preventing further investigation. Confirmation was received from the fse that after the power cycle, all manual e-stop and collision detection circuitry for collimator faces were tested and proved to be operating. Upon inspection, the fse noted the foot table pedestal was loose from the floor, which was due to the collision with the patient table. The detector 2 crystal was broken and lehr collimators on both detectors were damaged due to the collision with the patient table. There were no stuck buttons. The fse notified the user that the camera is to remain out of clinical use until parts could be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525965-2015-00288 |
| MDR Report Key | 5220984 |
| Date Received | 2015-11-12 |
| Date of Report | 2014-02-20 |
| Date Mfgr Received | 2014-02-20 |
| Date Added to Maude | 2015-11-12 |
| 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. DAN BROWN |
| Manufacturer Street | 595 MINER RD |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404833000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISM NUCLEAR GAMMA CAMERA SYSTEM |
| Generic Name | GAMMA CAMERA SYSTEM |
| Product Code | IYX |
| Date Received | 2015-11-12 |
| Model Number | N215003 |
| Catalog Number | 88201 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-11-12 |