CUSTOM ULTRASONICS SYSTEM 83 PLUS 9

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-01 for CUSTOM ULTRASONICS SYSTEM 83 PLUS 9 manufactured by Custom Ultrasonics.

Event Text Entries

[3024126] Gi technician noted clear liquid coming out of a processed endoscope. This tech then noted that two bulkhead connectors were not allowing flow. Bay was taken out of service. Hospital? S biomed staff was able to correct this by replacing swollen o-rings. Both connectors were then replaced by oem? S service rep on (b)(6) 2012. Flow from all connectors was verified by hospital biomed staff during a pm on (b)(6) 2012. When the oem service rep was first contacted on (b)(6), he was asked why this condition did not generate an alarm as that is what was expected according to the info the staff was given by the company. The service rep assured gi personnel that any bulkhead connector that had obstructed flow would generate alarms. A teleconference on (b)(6) 2012 with oem clarified that there is no flow obstruction alarm for individual bulkhead connectors on this system. The oem service rep that was on site on (b)(6), recommended to start a process to routinely check the flow of each channel/bulkhead. This is new instruction from the company and was not taught to hospital staff during custom ultrasonics? Installation in-services. It was also noted during the (b)(6) 2012 teleconference that custom ultrasonics does not have a process for updating operator and service manuals that are in use and ensuring their customers are following the latest operational and service guidance. Bay was placed back into service.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5027458
MDR Report Key2821119
Date Received2012-11-01
Date of Report2012-10-23
Date of Event2012-09-24
Date Added to Maude2012-11-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCUSTOM ULTRASONICS
Generic NameREPROCESSOR, ENDOSCOPE
Product CodeNVE
Date Received2012-11-01
Model NumberSYSTEM 83 PLUS 9
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCUSTOM ULTRASONICS
Manufacturer Address144 RAILROAD DRIVE IVYLAND PA 18974 US 18974


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-11-01

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