MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-01 for ADVANTAGE PLUS 1-2-510.003 manufactured by Medivators.
[143705960]
The facility reported employees developed exposure symptoms from rapicide pa high level disinfectant (hld) that leaked from their advantage plus automated endoscope reprocessor (aer). The facility reported the aer had a leak they could not locate. They reported hld ran onto the floor, then cleaned up with towels which were the placed in the dirty laundry hamper. After a couple hours, the employees reported a strong odor and noticed a haze in the room. One of the employees opened the hamper to find a thin cloud of fumes and reported the towels had some type of noticeable chemical breakdown. The facility used baking soda to neutralize the towels and chemical. Three employees reported symptoms of eye and throat irritation, nausea, headache and chest pain. The employees were sent to employee health and referred to ed for evaluation. They are reported to be fine. Medivators field service engineer arrived on site and repaired the leak. The machine was tested, and it ran within specification. The facility failed to follow the ifu and sds disposal instructions for rapicide pa hld. This complaint will continue to be monitored in the medivators complaint system.
Patient Sequence No: 1, Text Type: N, H10
[143705961]
The facility reported employees developed exposure symptoms from rapicide pa high level disinfectant that leaked from their advantage plus automated endoscope reprocessor (aer).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00034 |
| MDR Report Key | 8569468 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-04 |
| Device Manufacturer Date | 2012-08-10 |
| Date Added to Maude | 2019-05-01 |
| 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 | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | PM |
| 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 | 2019-05-01 |
| Model Number | 1-2-510.003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-01 |