MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2010-01-13 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..
[1416622]
The customer alleged the temperature of the water was very hot. The customer was concerned about damaging the scopes. The customer did not know the temperature of the disinfectant solution and was also unaware of the ambient temperature inside the unit. In addition, the customer stated the unit was turned off in the middle of the cycle and the temperature of the fluid was 127 degrees fahrenheit. There was condensation inside the unit. The customer stated the fumes from the disinfectant made him dizzy. The customer stated the room was small and did not have good ventilation. Subsequently, the customer stated four healthcare workers experienced adverse effects from the cidex opa fumes. The second healthcare worker experienced "dry throat, cough, shortness of breath, headache, itchy eyes, blurred vision, and increased heart rate". The healthcare worker was admitted to the er and was seen by an ophthalmologist and an occupational physician and was later discharged. The room was evacuated shortly after. The symptoms lasted three hours. The customer later stated the healthcare worker had completely recovered from the symptoms and returned to work. An asp field service engineer (fse) is scheduled to assess the unit on site.
Patient Sequence No: 1, Text Type: D, B5
[8511510]
Shortness of breath, cough, dry throat, itchy eyes, blurred vision, and increased heart rate. Capital equipment will be evaluated at the customer site. All related mdrs: 2150060-2010-00004, 2150060-2010-00005, 2150060-2010-00006.
Patient Sequence No: 1, Text Type: N, H10
[8922824]
Asp investigation summary: the investigation included a service history review, complaint trending by problem code, system hazard use and misuse analysis, failure mode and effects analysis, health hazard evaluation and corrective and preventative action. A review of the service history for this aer unit for six months, from (b)(4) 2009 through (b)(4) 2009, shows no similar hr issues and there are no trends with the aer unit emitting burning odor or fumes. The aer cpuy (complaints per unit year) was reviewed from (b)(4) 2009 through (b)(4) 2010 for pmcs (problem malfunction codes): "hr- eye burning" and "hr-allergic symptoms". Cpuy hr-eye burning: the cpuy trend drops initially and increases from (b)(4) 2009 to (b)(4) 2009. The trend line peaks for (b)(4) 2009, slightly above the ucl (upper control limit). The trend line decreases significantly after (b)(4) 2009 and levels out and stays below the ucl overall. Cpuy hr-allergic symptoms: the cpuy trend line increases and equals the ucl for (b)(4) 2009. The trend line decreases after 12/2009 and peaks again for (b)(4) 2010 but stays below ucl. It decreases significantly after (b)(4) 2010. The cidex opa solution/disopa shuma (system hazard use and misuse analysis) was reviewed and it was determined that the risks associated with cidex exposure are all category ii and are moderate. An assessment of the cidex opa solution fmea (failure mode and effects analysis) revealed the rpn (risk priority number) for hr-eye exposure is below the threshold of 100. The hhe (health hazard evaluation) was completed and the risk associated with such failures was found to be moderate. A capa (corrective and preventative action) has been opened to address the issue of aer not shutting off at the appropriate temperature due to failure of the thermistor, temperature sensor harness and/or microprocessor board. The concomitant product is gaseous fumes and odor from cidex opa solution. An asp ae (account executive) and a minntech (the external manufacturer) technician checked the aer unit at the customer's facility. The following issues were identified: the cidex opa was overheating. The temperature light was not coming on. The heater was not shutting off. . The temperature was recorded to be 89? F and was increasing. A bad connection to the board was found. The root cause for the aer unit overheating is known to be failure of the thermistor, temperature sensor harness and/or microprocessor board. A follow up with the customer indicated that the aer unit was taken out of service and was shipped to minntech.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2010-00003 |
| MDR Report Key | 1580025 |
| Report Source | *,05 |
| Date Received | 2010-01-13 |
| Date of Report | 2009-12-17 |
| Date of Event | 2009-12-17 |
| Date Mfgr Received | 2010-12-29 |
| 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 | 1465 28TH AVE. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0628-2011 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2010-01-13 |
| 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 | 2010-01-13 |