MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-11 for LUNAR PRODIGY manufactured by Datex-ohmeda Inc..
[4762030]
It was reported that while the scan arm of a lunar prodigy system was positioning going from a spine exam to a femur exam, the arm came into contact with the patient's left thigh. The technologist immediately looked at the patient's leg and observed bruising. The patient also sustained meniscus damage on the knee.
Patient Sequence No: 1, Text Type: D, B5
[12197271]
The initial report was filed on (b)(4) 2013 under the incorrect manufacturing site (b)(4). The correct manufacturing site is datex-ohmeda, (b)(4). (b)(4) investigation has been completed, the hospital's director of imaging confirmed that the scan arm was moving into position to scan the femur and was not in scan mode at this time. She also confirmed the collision occurred due to the patient's legs not being flat as required during the scan, therefore, the most probable root cause was use error. After further discussion with the site's director of risk management, she confirmed that they are not aware of any medical attention, intervention, nor tests for the patient. They have no confirmation of any diagnosis; and the patient has not had any visits to the site since the event. There are adequate instructions and mitigations in place on how to properly position the patient (user manual part number lu43616en rev. 14). No further actions are planned at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2112667-2014-00107 |
| MDR Report Key | 4106644 |
| Report Source | 05,06 |
| Date Received | 2014-09-11 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-11-05 |
| Date Mfgr Received | 2013-11-11 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2014-09-24 |
| 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 | PAUL CORRIGAN |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 531886794 |
| Manufacturer Country | US |
| Manufacturer Postal | 531886794 |
| Manufacturer Phone | 4142130021 |
| Manufacturer G1 | DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
| Manufacturer City | MADISON WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUNAR PRODIGY |
| Product Code | KGI |
| Date Received | 2014-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA INC. |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-11 |