MED PLUS GAS MANIFOLD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-22 for MED PLUS GAS MANIFOLD * manufactured by Hill-rom.

Event Text Entries

[20687171] Installation of a new medical gas system was installed and tested this date by hill-rom. The system was reported to have h20 in the lines and was subsequently purged with dry nitrogen. An independent testing report was issued by the independent testing group on 8/28/01 with no h20 present. The final testing was completed after purging the system with nitrogen and evacuation to remove h20. Since the system was first pressurized by hill-rom in 7/01, facility has had to replace six regulators in the medical gas manifold (o2). Currently the system does not work properly because it allows both the "in-use" and "reserve side" to equalize pressure. When this occurs the two banks equalize and diminish equally. This leaves the center without a reserve system or back-up oxygen supply. Hill-rom has indicated to facility's contractor that they will not warrant this oxygen manifold system because of the h20 report from early july. Facility has had to change out six pressure regulators in the system since the installation. They indicate that since water was in the system that they did not have to honor the warranty. Now that there is no water in the system the problem with the regulators still exists. Hill-rom claims no responsibility. With the type of system that it is the pressure from the regulators would not have introduced the water to the system since it is a high pressure to low pressure system. Facility continues to have problems and continues to have to pay "fee for svc" for repairs that it believes should be handled by the mfr.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1023185
MDR Report Key357633
Date Received2001-10-22
Date of Report2001-10-22
Date of Event2001-07-06
Date Added to Maude2001-10-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMED PLUS GAS MANIFOLD
Generic NameMEDICAL GAS MANIFOLD, OXYGEN
Product CodeCAM
Date Received2001-10-22
Model NumberMED PLUS
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key346851
ManufacturerHILL-ROM
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 470069167 US


Patients

Patient NumberTreatmentOutcomeDate
10 2001-10-22

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