MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-26 for ADVANTAGE PLUS manufactured by Medivators.
[143389304]
A facility reported that they had not performed the waterline disinfection (wld) cycle in their advantage plus automated endoscope reprocessor (aer) in accordance with the aer user manual, causing potential risk of contamination of endoscopes reprocessed in the aer. Medivators regulatory followed up with the facility and informed them of the wld requirements per the aer user manual. The facility reported the internal 0. 1 micron absolute bacterial retentive filter was replaced every 6 months as required. However, the facility failed to perform the wld cycle after replacing the filter. The number of endoscopes reprocessed during the 18-month timeframe is unknown. There have been no reports of patient harm. This complaint will continue being monitored in medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[143389305]
A facility reported that they had not performed the waterline disinfection (wld) cycle in their advantage plus automated endoscope reprocessor (aer) in accordance with the aer user manual, causing potential risk of contamination of endoscopes reprocessed in the aer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00031 |
| MDR Report Key | 8556946 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-03 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2019-04-26 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MEDIVATORS |
| 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 | 2019-04-26 |
| 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 MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-26 |