PHILIPS DIAG. CINE EQUIPMENT II SHIELD 9807-300-41101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-18 for PHILIPS DIAG. CINE EQUIPMENT II SHIELD 9807-300-41101 manufactured by Philips Medical Systems Na.

Event Text Entries

[21964223] During diagnostic cardiac procedure, cine equipment failed to display video pictures on the monitor. Co's repair technician immediately came into the room and adjustments were made. Cine video continued to be faulty where dr could not visualuze cine run. Procedure incomplete. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number26853
MDR Report Key26853
Date Received1995-07-18
Date Added to Maude1995-10-06
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 NamePHILIPS DIAG. CINE EQUIPMENT II SHIELD
Generic NamePHILIPS DIAG. CINE EQUIPMENT II SHIELD
Product CodeIWO
Date Received1995-07-18
Catalog Number9807-300-41101
Lot Number1704580.046
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key27635
ManufacturerPHILIPS MEDICAL SYSTEMS NA


Patients

Patient NumberTreatmentOutcomeDate
101. No Informationnvalid Deathata 1995-07-18

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