MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EASYDIAGNOST ELEVA; TABLE, RADIOGRAPHIC, TILTING

Device Problems Failure to Transmit Record (1521); Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2019

Event Type  malfunction  

Event Description

This customer had a cystogram completed.There were several digital images taken during the fluoroscopy portion, and then an overhead x-ray after the procedure was completed.The technicians attempted to send the digital images to pacs.They were unable to get the digital images to transfer.After attempts made by a supervisor to resolve the issue to get the images to go (has been successful at times before), were unsuccessful, the supervisor contacted philips to assist.The representative made several attempts to resend the study, but the rep determined that the digital images were ultimately lost.There was the one overhead image that was sent to pacs and the radiologist was still able to provide a diagnosis.Biomedical engineering records: equipment passed preventative maintenance performed by philips on 3/18/19.Equipment passed medical physicist's fluoroscopy performance test summary on 5/16/19.

• Brand Name: EASYDIAGNOST ELEVA
• Type of Device: TABLE, RADIOGRAPHIC, TILTING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 595 miner road; cleveland OH 44143
• MDR Report Key: 9069615
• MDR Text Key: 158630551
• Report Number: 9069615
• Device Sequence Number: 1
• Product Code: IXR
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA