FDA.reportPublic FDA data

MAUDE MDR 603607

MDR report key
603607
Report number
603607
Event key
0
Event type
3
Date of event
2005-03-23
Date received
2005-05-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADUANESTHESIA MACHINEDATEX -OHMEDABSZADU**NR
2ONEACUNINTERRUPTIBLE POWER SUPPLY, UPSONEACMPE***NR
3ONEACUNINTERRUPTIBLE POWER SUPPLY, UPSONEACMPE***NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-05-060

Event Narratives#

D

Patient 1

PER YOUR LETTER DATED 5/31/2005 REQUESTING A FAILURE ANALYSIS OF SUBJECT REPORT, DATEX-OHMEDA HAS RECEIVED A RESPONSE FROM ONEAC, THE MFR OF THE UPS UNIT INVOLVED IN THE ALLEGED EVENT. THEIR RESPONSE IS QUOTED AS FOLLOWS: "THE UPS USED BY DATEX-OHMEDA DOES THE FOLLOWING: 1. IS A MEDICAL GRADE UPS OFFERING LOW ELECTRICAL CUMULATIVE LEAKAGE FOR THE UPS AND CONNECTED EQUIPMENT OF LESS THAN 300 MICROAMPS 2. PROVIDE SURGE PROTECTION FOR CONNECTED EQUIPMENT 3. BATTERY BACKUP IN HIGH LINE, LOW LINE, AND NO POWER. 4. THE UPS ALARMS WHEN IT GOES TO BATTERY HAVING RECEIVED SOME OF THE UPSS BACK FROM THE HOSP AND AFTER TALKING TO DATEX-OHMEDA PERSONNEL, ONEAC BELIEVES THE FOLLOWING OCCURRED AND WOULD LIKE THIS ADDED TO YOUR MEWATCH RESPONSE: 'THE ONM600SJ-SI FUNCTIONED BY GOING TO BATTERY BACK UP UNDER A FAULTY MAINS CONDITION, THUS KEEPING THE ATTACHED EQUIPMENT FUNCTIONAL UNDER THESE CONDITIONS. UPON DEPLETION OF THE BATTERIES, WITH FAULTY MAIN CONDITIONS SILL PRESENT, THE UPS TURNED OFF, EITHER DUE TO COMPLETE LOSS OF MAINS, OR TO PROTECT THE ATTACHED EQUIPMENT FROM THE FAULTY MAINS CONDITION. THE UPS FUNCTIONED PROPERLY IN THESE ACTIONS."

D

Patient 1

THE DATEX OHMEDA ANESTHESIA MACHINE CONTAINS TWO UNINTERRUPTIBLE POWER SUPPLIES (UPS) FOR SURGE PROTECTION. THE BATTERIES FAILED IN BOTH OF THE UPS ON THE ANESTHESIA MACHINE AND SHUT IT DOWN. THE MONITORING AND THE MACHINE ARE RUN FROM THE UPS. THE OR STAFF AND BIOMED HAD TO SCRAMBLE TO PLUG IN EACH DEVICE INTO A LIVE A/C OUTLET. THE TWO UPS'S SUPPLIED BY DATEX OHMEDA ARE MANUFACTURED BY ONEAC. FACILITY BELIEVES THESE UPS UNITS ARE NOT REQUIRED ON THESE UNITS. THEY ARE MORE OF A LIABILITY THAN AN ASSET.