MAUDE Adverse Event Report: AGFA NV PORTABLE RADIOGRAPHY UNIT; FILM, RADIOGRAPHIC

Model Number DX-D100

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2022

Event Type  malfunction  

Event Description

During a routine patient imaging procedure using an agfa dx-d 100 portable radiographic unit, the counter weight cable snapped and the horizontal arm with attached x-ray tube head fell toward the patient bed.The x-ray head collimator landed on the bed railing and that stopped the fall.Neither patient nor personnel were harmed by the cable failure.After the incident our engineer inspected this agfa dx-d 100 and determined that following the counter weight cable failure, tension was not released from the cable attached to the backup safety latch.Since tension was not released, the backup safety latch did not engage the vertical arm and stop the x-ray head from falling toward the bed.

• Brand Name: PORTABLE RADIOGRAPHY UNIT
• Type of Device: FILM, RADIOGRAPHIC
• Manufacturer (Section D): AGFA NV; mortsel ; BE
• MDR Report Key: 16352924
• MDR Text Key: 309405904
• Report Number: MW5114843
• Device Sequence Number: 1
• Product Code: IWZ
• Combination Product (y/n): N
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DX-D100
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1