MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-10-20 for SOPHYCAMERA DSX RECTANGULAR P10002 NA manufactured by Smv Intl.
[953410]
It was reported at this site that collimator on a smv dsx nuclear camera fell from its detector head onto the floor, while the operator was setting up to perform a pt scan. The collimator weighs approximately 150 lbs. No injury was reported, and no contact between the collimator and either pt or operator occurred. Although a pt was on the system's table, the table was not immediately beneath the detectors at the time. The setup procedure is generally performed, prior to pt positioning under the detector head. However, this issue could potentially result in a serious injury, or could potentially be life threatening, if the collimator were to contact the operator or pt.
Patient Sequence No: 1, Text Type: D, B5
[8213682]
Ge engineering visited the site and investigated the issue. The system had been experiencing a slight shift between the collimator and detector head for some time due to a missing guide pin in the detector head. It is not significant enough to result in any potential collimator falling hazard. However, the system would indicate that the collimator was not properly latched at times, despite it actually being latched adequately. Therefore, the operators at this site became accustomed to bypass the safety warnings provided by the system. Additionally, it was determined that this site had one safety sensor switch permanently bypassed so that it read latched at all times. In this instance, the technician did not latch the collimator to the detector head properly on one side. Because of the bypass issue, there was one sensor indicating unlatched, when in actuality there should have been two sensors indicating unlatched. The operator then bypassed this safety warning. As the gantry was rotated, the front side of the collimator began to slide out of the detector. Since the one side was not latched at all, the collimator was allowed to completely detach from the detector head and fall to the floor. The site has been corrected by several site visits, inspection by engineering personnel, and replacement or repair of damaged parts and safety mechanisms.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615727-2008-00001 |
| MDR Report Key | 1204591 |
| Report Source | 05 |
| Date Received | 2008-10-20 |
| Date of Report | 2008-09-22 |
| Date of Event | 2008-09-22 |
| Date Mfgr Received | 2008-09-22 |
| Device Manufacturer Date | 1992-03-01 |
| Date Added to Maude | 2009-04-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTHA KAMROW |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | SMV INTL. |
| Manufacturer Street | 105, AVENUE MORANE SAULNIER |
| Manufacturer City | BUC 78534 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 78534 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOPHYCAMERA DSX RECTANGULAR |
| Product Code | IYX |
| Date Received | 2008-10-20 |
| Model Number | P10002 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMV INTL |
| Manufacturer Address | 105, AVENUE MORANE SAULNIER BUC 78534 FR 78534 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-20 |