MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-01 for PRODIGY manufactured by Ge Healthcare.
[16104325]
There is an allegation that a pt sustained an injury after a bone density exam performed in (b)(6) 2010. During the exam the scan arm of the ge prodigy system came into contact with one of her knees. One month following the event, the pt stated she had undergone an mri that diagnosed her with a medial meniscus tear. It is not known the treatment the pt received as a result of this diagnosis.
Patient Sequence No: 1, Text Type: D, B5
[16326489]
Since the incident occurred more than two years ago, the only info available is what was provided by the initial reporter. The system was under ge healthcare service contact until (b)(4) 2010, and no issues related to this issue were noted. The system was not evaluated prospectively by ge healthcare since this will not provide any valuable info considers the incident occurred back in 2010. At the time of the incident the technologist activated the emergency stop when the pt alerted that the scan arm had impacted her. After the incident the tech made several attempts to have pt see a physician prior to leaving, but she refused. The hospital technologist stated that she performed scans on other pts following this incident; including the same day, and has no reoccurrence of this event. The technologist also stated that the system did not malfunction at the time of the incident, and that preventative maintenance has been performed on the system on a regular basis by a third party service provider. As per design, the unit is equipped with emergency stop buttons and the movement of scan arm is limited in speed and force. No further actions are planned at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124823-2012-00137 |
| MDR Report Key | 2829634 |
| Report Source | 05,06 |
| Date Received | 2012-11-01 |
| Date of Report | 2012-10-02 |
| Date of Event | 2010-08-01 |
| Date Mfgr Received | 2012-10-02 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2012-11-14 |
| 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 | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRODIGY |
| Generic Name | BONE DENSITOMETER |
| Product Code | KGI |
| Date Received | 2012-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | MILWAUKEE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-01 |