ATHENA MONIITOR 9541 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-04 for ATHENA MONIITOR 9541 UNKNOWN manufactured by Narco Medical Services, Athena.

Event Text Entries

[19549712] The recorders on the athena systen would go to sleep on the system. By this we mean that they would log off the network and we could not get any alarm or manual recordings on the system. To correct this problem we would have to turn off the recorder for one or two minutes so that it could reset itself. This would work for a while then it would happen again and we would have to do the same thing. As you can see if you were trying to get documentation on a patient problem it was next to impossible. Manufacturers are aware of this problem and are working on it. They feel that the problem is the software and they are rewriting the software to correct this problem. As an intermin fix they have installed min ups systems so that power can not be interupted. This has not solved the problem as we have had to rest the recorders stillinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-oct-92. Service provided by: factory trained/authorized/owned service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, mechanical tests performed, visual examination. Results of evaluation: electrical problem, none or unknown, recorder, central processing unit/operating system failure/bug. Conclusion: device failure related to patient condition. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1658
MDR Report Key1658
Date Received1992-11-04
Date of Report1992-10-27
Date of Event1992-05-01
Date Facility Aware1992-05-01
Report Date1992-10-27
Date Reported to FDA1992-10-27
Date Reported to Mfgr1992-05-01
Date Added to Maude1992-11-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameATHENA MONIITOR
Generic NameATHENA RECORDER
Product CodeDSF
Date Received1992-11-04
Model Number9541
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
ID NumberUNKNOWN
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant Flag*
Device Sequence No1
Device Event Key1575
ManufacturerNARCO MEDICAL SERVICES, ATHENA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1992-11-04

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