AMICO CORP. MICRO PROCESSOR BASED DIGITAL MANIFOLD ALERT - 2 M2LT-D-HH-U-AIR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-24 for AMICO CORP. MICRO PROCESSOR BASED DIGITAL MANIFOLD ALERT - 2 M2LT-D-HH-U-AIR * manufactured by Amico Corp.

Event Text Entries

[301259] Pt transferred to this facility from tertiary care for ongoing care. Pt receiving 28% blended oxygen. This facility has a two manifold bank system from medical air. Each bank consists of four h tanks of medical air, when one bank is in use the other sits in reserve. As soon as the bank in use is depleted the system automatically switches to the reserve bank and the empty tanks are replaced. In 2003, medical air alarms began sounding-left band reading empty, right bank reading low pressure. Previous pressure readings indicated sufficient quantity of medical air. System assessed - no line leaks found. Depleted bank tanks replaced. Two days later, same incident occurred - one bank depleted, one bank low. Again, no line leaks found. Tanks switched out. Investigation of incidents continued with assessment of blender in use. Found that the blender was not a low flow blender. Set up switched to low flow blender. While the blender that was in use would use more medical air than a low flow blender this would not account for the significant loss of medical air that was experienced. Ongoing investigation into the manifold system found that the pressure line was giving a false pressure reading. When one bank depletes and the system automatically switches over the empty bank started pressurizing again. The pressure line contains a shuttle valve that should seal off when the bank switches, however, it was found that the medical air would blow by the shuttle valve back into the heater bar pressurizing it and cancelling the empty alarm thus giving a false pressure reading. Since replacing the shuttle valve there have been no further incidents with loss of medical air.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1029060
MDR Report Key473759
Date Received2003-07-24
Date of Report2003-06-02
Date of Event2003-03-21
Date Added to Maude2003-07-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAMICO CORP. MICRO PROCESSOR BASED DIGITAL MANIFOLD ALERT - 2
Generic NameMEDICAL GAS MANIFOLD
Product CodeCAM
Date Received2003-07-24
Model NumberM2LT-D-HH-U-AIR
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key462609
ManufacturerAMICO CORP
Manufacturer Address21-121 GRANTON DRIVE RICHMOND HILL, ONTARIO CA L4B 3N4
Baseline Brand NameAMICO CORP MICROPROCESSOR BASED DIGITAL MANIFOLD ALERT-2
Baseline Generic NameMEDICAL GAS MANIFOLD
Baseline Model NoM2LT-D-HH-U-AIR
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-07-24

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