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..
[1448976]
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 fourth healthcare worker experienced "shortness of breath, wheezing, itchy face and nose, headache, dizziness, blurred vision, runny nose, pale and increased heart rate and blood pressure". The symptoms lasted for 1-2 hours; the headache lasted for two days. The healthcare worker was admitted to the er and was later discharged. The room was evacuated shortly after. 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
[8497282]
Shortness of breath, wheezing, itching of face and nose, blurred vision, runny nose, and increased heart rate and blood pressure. Capital equipment will be evaluated at the customer site. All related mdrs: 2150060-2010-00003, 2150060-2010-00004, 2150060-2010-00006.
Patient Sequence No: 1, Text Type: N, H10
[8870613]
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, and health hazard evaluation. 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 per the service history. The aer cpuy (complaints per unit year) was reviewed from (b)(4) 2009 through 10/(b)(4) 2010 for pmc (problem malfunction code): "hr-allergic symptoms. " the cpuy trend line increases and equals the ucl (upper control limit) for (b)(4) 2009. After (b)(4) 2009, it decreases 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 which was locked up at a storage site at the 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2010-00005 |
| MDR Report Key | 1580013 |
| 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 | 14605 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 |