MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-12 for TROPHON? EPR TROPHON EPR manufactured by Ge Healthcare.
[97120351]
Patient Sequence No: 1, Text Type: N, H10
[97120352]
Patient diagnosed with localized prostate cancer presented to the surgery clinic for a surveillance prostate ultrasound. The patient was brought to the ultrasound suite and placed in the left lateral decubitus position. The ultrasound probe was then inserted into the rectum and serial transverse and longitudinal images were obtained. The prostate volume and the transition zone volume were calculated. The prostate and svs were inspected for areas of hypoechogenicity, and a power doppler exam was performed. The patient tolerated the procedure well and was released from the exam room uneventfully. During the qa review of the log associated with the trophon machine used to disinfect the ultrasound probe used with patient a, it was discovered that the high level disinfection cycle (hld) following the previous procedure using the probe had failed. This suggested that patient a was exposed to an ultrasound probe that had not been adequately disinfected. An error code (b)(4) was listed on the trophon label associated with the failure cycle. After researching the error code and downloading the machine log files, it was determined the failure was due to the temperature not reaching the target value. The temperature during the disinfection cycle reached 55. 6 degrees which did not meet the expected temperature minimum of 56 degrees. Since the other parameters were met, it was decided the probe was in fact adequately disinfected and posed no risk to the patient. The problem is when a cycle fails; it is easy for the operators to miss this fact since the only indication is on the small stickers printed by the machine. It would be better if there was a more obvious indicator of a failed cycle, such as the door staying locked until the operator acknowledges the load has failed. The operator may not be present when the cycle completes. It is also very difficult to view the log files from previous cycles. It requires a pc and proprietary software and cable. Error messages are not easily deciphered and we have to contact the manufacturer to interpret.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7185400 |
| MDR Report Key | 7185400 |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-08-29 |
| Report Date | 2018-01-03 |
| Date Reported to FDA | 2018-01-03 |
| Date Reported to Mfgr | 2018-01-03 |
| Date Added to Maude | 2018-01-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROPHON? EPR |
| Generic Name | HIGH LEVEL DISINFECTION UNIT |
| Product Code | OUJ |
| Date Received | 2018-01-12 |
| Model Number | TROPHON EPR |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 3000 N. GRANDVIEW BLVD W-450 WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-12 |