MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-24 for DSD-201 manufactured by Medivators Inc..
[143035105]
A medivators field service engineer (fse) reported a facility had not been using test strips to test the minimum required concentration (mrc) of the high-level disinfectant before each reprocessing cycle in their dsd-201 automated endoscope reprocessor (aer). There is potential that the disinfectant cycle did not reach high-level disinfection, thus there is potential for patient cross-contamination. It is required per the aer user manual to monitor mrc levels. Additionally, the rapicide glutaraldehyde indicator test strip directions for use indicate that the disinfectant should be tested for mrc before each cycle. The number of endoscopes reprocessed without checking mrc is unknown. Medivators fse informed the facility that it is required to test mrc before each disinfectant cycle. There have been no reports of patient adverse events. This complaint will continue to be monitored in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[143035106]
A medivators field service engineer (fse) reported a facility had not been using test strips to test the minimum required concentration (mrc) of the high-level disinfectant before each reprocessing cycle in their dsd-201 automated endoscope reprocessor (aer). There is potential that the disinfectant cycle did not reach high-level disinfection, thus there is potential for patient cross-contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00032 |
| MDR Report Key | 8547191 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-04-04 |
| Device Manufacturer Date | 2009-06-25 |
| Date Added to Maude | 2019-04-24 |
| 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 | DSD-201 |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | FEB |
| Date Received | 2019-04-24 |
| 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 | 2019-04-24 |