MAUDE Adverse Event Report: ZIEHM IMAGING INC. VISION R-FD FLAT PANEL DIGITAL MOBILE C-ARM; DIGITAL MOBILE C-RAM

Model Number VISION R-FD FLAT PANEL DIGITAL M

Device Problems Image Orientation Incorrect (1305); Computer Operating System Problem (2898); Material Deformation (2976); Protective Measures Problem (3015); Patient Data Problem (3197)

Patient Problem No Code Available (3191)

Event Date 07/20/2015

Event Type  malfunction  

Event Description

Acquired x-ray images display sideways.This has been reported to the mfr (ziehm imaging, inc.) as of (b)(6) 2015 and there has been no clinically viable permanent solution to address this problem.From clinical perspective, this can be pt safety issue as images are mislabeled and can be misinterpreted.We have samples of images that have been sent to the mfr with no response on when this will be fixed.Instead workarounds were proposed rather than solving the underlying product problem.These workarounds take more time than is necessary and prolong the pt's medical procedure.

• Brand Name: VISION R-FD FLAT PANEL DIGITAL MOBILE C-ARM
• Type of Device: DIGITAL MOBILE C-RAM
• Manufacturer (Section D): ZIEHM IMAGING INC.; orlando FL 32822
• MDR Report Key: 5986603
• MDR Text Key: 56025911
• Report Number: MW5065085
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VISION R-FD FLAT PANEL DIGITAL M
• Device Catalogue Number: 302803-AV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 98