SONY MONITOR PVM-2030 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-01 for SONY MONITOR PVM-2030 * manufactured by Sony Corp Of America.

Event Text Entries

[21792] A video monitor that had been installed recently in the center had a malfunctioning vertical hold. There was potential danger to the pt because this is the only method of viewing the inside of the colon during a procedure. The screen on the video monitor is used to direct the physician during the procedure. No apparent injury occured to the pt during the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1010015
MDR Report Key40400
Date Received1996-10-01
Date of Report1996-09-19
Date of Event1996-09-04
Date Added to Maude1996-10-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSONY
Generic NameVIDEO MONITOR
Product CodeEXZ
Date Received1996-10-01
Returned To Mfg1996-09-13
Model NumberMONITOR PVM-2030
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key41514
ManufacturerSONY CORP OF AMERICA
Manufacturer Address3 PARAGON DR MONTVALE NJ 07645 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1996-10-01

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