MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2009-10-13 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..
[1743718]
Patient Sequence No: 1, Text Type: D, B5
[8812107]
Asp investigation summary: the investigation included a service history review, device history record, complaint trending by problem, failure mode, and effects analyses, system hazard and user misuse analysis, and health hazard evaluation. A review of the dhr (device history record) for the aer (automatic endoscope reprocessor) shows that the finished product met manufacturer's specifications and passed all tests at the time of release. A review of the service history for six months prior to this issue, from (b)(4) 2009 through (b)(4) 2009, shows a trend with the unit leaking more than a maximum of three times. However, there is no trend with the replaced parts. The aer cpuy (complaints per unit year) trend for problem "fluid leak" from (b)(4) 2009 to (b)(4) 2010, was completed. The trend line is below the ucl (upper control limit) for all twelve months. The trend is not significant overall. The aer fmea (failure mode and effects analysis) was reviewed and the rpns (risk priority numbers) due to failures to the unit are below 100 and are considered low risk for this unit. An assessment of the cidex opa solution fmea (failure mode and effects analysis)) revealed the risk priority number (rpn) for spills/ leaks is below the threshold of 100, indicating that the associated risk is minimal. The cidex opa shuma (system hazard and user misuse analysis) was reviewed and it was determined that the risks associated with cidex spills are all category i; therefore, no further action is required at this time. The concomitant product is a combination of cidex disinfectant and water. No further actions are required for this issue.
Patient Sequence No: 1, Text Type: N, H10
[17024217]
The customer alleged, the unit stopped in the middle of a cycle and did not start back up. The unit was leaking a small amount of cidex brand solution from the bottom right-hand corner. The customer rebooted the unit, the control panel stop light came on, but the unit did not start. The customer cleaned up the leak. No injuries or adverse events were involved. A field service engineer (fse) went to the facility to assess the unit.
Patient Sequence No: 1, Text Type: D, B5
[17232517]
The vendor evaluated at the customer's site. The field service engineer (fse) found the control panel was not responding. The fse replaced it and provided the customer with a wrench for the filter replacement. During the inspection, the fse determined leaks throughout the unit caused by external factors: the customer had facility issues that resulted in excessive hot water running through the unit. The excessive heat caused warping of the valve stems resulting in leaks from the manifold and inlet valve. At this time, the customer has not come to a decision on whether to repair the unit or not. The unit is not in use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00157 |
| MDR Report Key | 1511038 |
| Report Source | *,05 |
| Date Received | 2009-10-13 |
| Date of Report | 2009-09-18 |
| Date of Event | 2009-09-18 |
| Date Mfgr Received | 2010-11-30 |
| Date Added to Maude | 2011-01-27 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GINNY STAMBERGER |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | MINNTECH CORP. |
| Manufacturer Street | 14605 28TH AVE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-10-13 |
| Model Number | NA |
| Catalog Number | 20301 |
| Lot Number | NA |
| ID Number | PART #: NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINNTECH CORP. |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-13 |