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 Number: 26853
• MDR Report Key: 26853
• Date Received: 1995-07-18
• Date Added to Maude: 1995-10-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PHILIPS DIAG. CINE EQUIPMENT II SHIELD
• Generic Name: PHILIPS DIAG. CINE EQUIPMENT II SHIELD
• Product Code: IWO
• Date Received: 1995-07-18
• Catalog Number: 9807-300-41101
• Lot Number: 1704580.046
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 27635
• Manufacturer: PHILIPS MEDICAL SYSTEMS NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1995-07-18