ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301

MAUDE Adverse Event Report

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.

Event Text Entries

[15535607]
Patient Sequence No: 1, Text Type: D, B5


[15848539] 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 pmc (problem malfunction code): "hr-allergic symptoms". (b)(4). 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 (b)(4). 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. 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


[22100813] 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 third healthcare worker experienced "shortness of breath, dizziness, burning/itchy nose, an increased heart rate and blood pressure". The symptoms lasted for 1-2 hours. 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


[22118290] Shortness of breath, burning/itchy nose, increased heart rate and blood pressure. Capital equipment will be evaluated at the customer site. All related mdrs: 2150060-2010-00003, 2150060-2010-00005, 2150060-2010-00006.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2150060-2010-00004
MDR Report Key1580014
Report Source*,05
Date Received2010-01-13
Date of Report2009-12-17
Date of Event2009-12-17
Date Mfgr Received2010-12-29
Date Added to Maude2011-01-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactGINNY STAMBERGER
Manufacturer Street33 TECHNOLOGY DR
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9497893837
Manufacturer G1MINNTECH CORP
Manufacturer Street14605 28TH AVE NORTH
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-0628-2011
Event Type3
Type of Report3

Device Details

Brand NameASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
Generic NameAER EQUIPMENT
Product CodeNVE
Date Received2010-01-13
Model NumberNA
Catalog Number20301
Lot NumberNA
ID NumberPART #: NA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMINNTECH CORP
Manufacturer AddressMINNEAPOLIS MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
10 2010-01-13

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