MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-07 for GE HLD TROPHON N00010 manufactured by Ge Medical Systems.
[66808843]
The ge hld trophon device is used on the l and d unit for disinfecting probes. The 35 percent hydrogen peroxide solution was noted to have leaked onto the countertop and floor. The nurse did not notice until it soaked through her pant leg and became bubbly red, then white. After touching her pant leg and countertop with her hand, the nurse felt the burning. She immediately notified the charge nurse and the manufacturer was contacted. Appropriate action was taken. Four nurses and pct's were exposed by direct contact and/or by the fumes to the h2o2 chemical. They were evaluated by occupational health as per the recommendation of the manufacturer. Event: 4 oz container of 35 percent solution of hydrogen peroxide leaked onto counter top and floor; new hdl supplied to the unit. Hdl unit involved in event returned to manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067737 |
| MDR Report Key | 6311528 |
| Date Received | 2017-02-07 |
| Date of Report | 2017-02-07 |
| Date of Event | 2017-02-01 |
| Date Added to Maude | 2017-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE HLD TROPHON |
| Generic Name | TROPHON HIGH LEVEL DISINFECTOR |
| Product Code | OUJ |
| Date Received | 2017-02-07 |
| Returned To Mfg | 2017-02-06 |
| Model Number | N00010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS |
| Manufacturer Address | WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-07 |