MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2009-12-07 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corporation.
[1752567]
Patient Sequence No: 1, Text Type: D, B5
[8851909]
(b)(4) - valve. Asp investigation summary: the investigation included a review of the service and complaint history, trending by product line and system serial number and failure mode and effects analysis. A review of the dhr (device history review) for the aer (automatic endoscope preprocessor) is not required since the root cause is known to be a failure due to normal wear and tear of the skinner valve. As per the service history for this aer, there has been no e01 (reservoir tank too full) issues causing the reservoir to fill up and lead to a fluid leak, particularly, in six months prior to the date of the event in (b)(6) 2009. This is the first time the disinfectant reservoir valve-v7 (skinner valve) has been replaced on this unit. A review of the fmea (failure mode and effects analysis ) for the unit showed that all leak failure modes have overall risk numbers below the threshold of 100. A review of the account history for this unit from (b)(4) 2009, shows this unit does not demonstrate a trend for leaking. The useful life of the skinner valve assembly is 2 years of 2000 hours of operation. The skinner valve has not been replaced since the installation of the unit on (b)(6) 2006, to the date of the event in (b)(6) 2009. Hence, the skinner valve failed due to normal wear and tear.
Patient Sequence No: 1, Text Type: N, H10
[21679196]
The customer alleged the tubing would not reconnect to the unit thus a solution leaked. The facility's biomedical engineer group attempted to repair the unit. The customer stated the disinfectant reservoir was too full and was leaking through the vent tube. A cycle was processing. An eo1 message appeared; the tank-high light on the microprocessor board was illuminated. The customer stated a disinfectant solution leaked outside the unit. There were no injuries involved. An asp field service engineer (fse) went to the facility to assess the unit.
Patient Sequence No: 1, Text Type: D, B5
[21819225]
Capital equipment evaluated at the customer site. The field service engineer (fse) found the reservoir tank too full. The skinner valve #7 was leaking, causing the reservoir tank to overfill. The fse replaced the skinner valve assembly to resolve the issue. The unit conformed to the manufacturer's specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00172 |
| MDR Report Key | 1556475 |
| Report Source | *,05 |
| Date Received | 2009-12-07 |
| Date of Report | 2009-11-12 |
| Date of Event | 2009-11-12 |
| Date Mfgr Received | 2010-10-08 |
| Date Added to Maude | 2011-01-26 |
| 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 | 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 CORPORATION |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-12-07 |
| 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 CORPORATION |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-07 |