MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-02-08 for PRISM 2000 GAMMA CAMERA 4535 665 12911 manufactured by Philips Medical Systems (cleveland), Inc..
[794506]
Technician was loading the megap-par (medium energy all purpose-parallel) collimator on to detector head 2 for a new pt scan. Megap-par collimator separated from the detector head shortly after loading. The collimator was held to the head by safety latch. No injury to pt or operator occurred.
Patient Sequence No: 1, Text Type: D, B5
[8094066]
Initial investigation determined the following: the collimator id board on head 2 was shimmed out. As a result, the detector falsely sensed the collimator was latched. The block on the id board was damaged. It was determined that the system was under third party service. The last preventive maintenance was conducted in 2006. Engineering review of the phots taken at the site determined that further investigation at the site was necessary. During a site visit, a philips technical support engineer observed the following: the gantry covers were missing several clips. This prevents a secure attachment of the front and rear cover. There is a collection of metal shavings on the detector. This was most likely the result of the rubber cushion on the detector being very worn. When the detector is rotated, the shavings could fall in the pt's eyes. The collimator server cart had been modified by removing the top safety catches (intended to prevent the collimator from falling during exchange). The wrap around the gantry power cables was split. All the cables inside were in good condition and none of the insulation was damaged. The most probable root cause of these issues is improper maintenance performed by the customer. There was no serious injury to pt or operator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2008-00006 |
| MDR Report Key | 1002924 |
| Report Source | 06,07 |
| Date Received | 2008-02-08 |
| Date of Report | 2008-02-08 |
| Date Mfgr Received | 2008-01-09 |
| Device Manufacturer Date | 1996-02-16 |
| Date Added to Maude | 2008-09-02 |
| 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 | MELINDA NOVATNY |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404834255 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISM 2000 GAMMA CAMERA |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2008-02-08 |
| Model Number | 4535 665 12911 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1000543 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Address | CLEVELAND OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-08 |