MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-04 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR AER387 manufactured by Minntech Corp..
[1513520]
The customer alleged a leaking reservoir and an eo5 message. The customer stated no adverse reactions were involved from the leak. The unit was taken out of service. Advanced sterilization products (asp) later contacted the customer, she stated the cidex opa solution leaked onto the floor. No injuries were involved. The customer cancelled the service request and resolved the issue. The unit has been in operation.
Patient Sequence No: 1, Text Type: D, B5
[8317520]
Capital equipment evaluated at the customer site. The customer resolved the issue. Customer resolved the issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00170 |
| MDR Report Key | 1556449 |
| Report Source | 05 |
| Date Received | 2009-12-04 |
| Date of Report | 2009-11-09 |
| Date of Event | 2009-11-09 |
| Date Mfgr Received | 2009-11-09 |
| Date Added to Maude | 2010-03-05 |
| 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 TECH. DR. |
| 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 |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-12-04 |
| Model Number | NA |
| Catalog Number | AER387 |
| 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 | 2009-12-04 |