MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH BUCKY DIAGNOST; SYSTEM, X-RAY, STATIONARY

Model Number BUCKY DIAGNOST FS S

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

Table bucky was not sensing any cassettes.There was no auto collimation possible.Error code (cassette not centric) problem did not resolve with restarting equipment.Error code persists even with 14x17 cassette.Had to retake test and there was a delay in treatment.

• Brand Name: BUCKY DIAGNOST
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; 100 park avenue; suite 300; orange village OH 44122
• MDR Report Key: 10860124
• MDR Text Key: 216866051
• Report Number: 10860124
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BUCKY DIAGNOST FS S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1