MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-25 for ADVANTAGE PLUS manufactured by Medivators Inc..
[143244211]
A facility reported that two staff members experienced chemical exposure symptoms from rapicide pa high level disinfectant (hld) fumes during a reprocessing cycle using their advantage plus automated endoscope reprocessor (aer). The facility reported the staff exposure to the hld fumes occurred when their aer issued a communication error during the disinfect phase of a reprocessing cycle causing the cycle to stop when the basins were filled with diluted hld use-solution. The facility then sealed off the reprocessing room and a medivators field service engineer (fse) was dispatched to repair the device. Medivators fse determined the communication error was due to a failed circuit board within the aer. Medivators fse replaced the circuit board which allowed the drain valves to activate and empty the aer basins. The aer was returned to service after confirming it was operating according to specification. Medivators regulatory followed up with the facility for further information regarding the staff who experienced chemical exposure symptoms to the hld fumes. The facility reported the two affected staff members sought medical attention for itchy skin and trouble breathing but that symptoms improved within 24 hours and they are doing fine. This complaint will continue to be monitored in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[143244212]
A facility reported that two staff members experienced chemical exposure symptoms from rapicide pa high level disinfectant fumes during a reprocessing cycle using their advantage plus automated endoscope reprocessor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00035 |
| MDR Report Key | 8551998 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2011-02-28 |
| Date Added to Maude | 2019-04-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANNAH SHRADER |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635596863 |
| Manufacturer G1 | MEDIVATORS INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTAGE PLUS |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | FEB |
| Date Received | 2019-04-25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-25 |