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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-09 for * manufactured by *.

Event Text Entries

[2223702] While checking the isolation monitor (lim) a facility staff member noticed the unit was in alarm and the meter indication at maximum. He isolated the circuit that was causing the alarm and shut that breaker off. Cath lab staff was requesting use of the room even though the isolation panel was alarming. Fault was caused by the power unit for an acist injector. When staff had been cleaning up after their previous case, the fluid bag that has been used with the injector came 'un-spiked' and fluid spilled on the power unit located directly below on the floor. Fluid infiltrated the power unit rendering it non-operational and caused the line isolation fault. Visual inspection inside the power unit revealed dried solution in several locations indicating that this is not necessarily the first time liquid has infiltrated the compartment. No patient was being treated at the time. ======================manufacturer response for injector, (brand not provided). ======================problem was result of operator abuse. Power unit is being repaired and returned to us.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2316531
• MDR Report Key: 2316531
• Date Received: 2010-06-09
• Date of Report: 2010-04-26
• Date of Event: 2010-04-08
• Report Date: 2010-04-26
• Date Reported to FDA: 2010-06-09
• Date Added to Maude: 2011-11-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: LINE ISOLATION MONITOR
• Product Code: DRI
• Date Received: 2010-06-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: *
• Generic Name: INJECTOR
• Product Code: DXT
• Date Received: 2010-06-09
• Returned To Mfg: 2010-04-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ACIST MEDICAL SYSTEMS
• Manufacturer Address: 7905 FULLER RD EDEN PRAIRIE MN 55344213 US 55344 2137

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-06-09