MAUDE Adverse Event Report: SEDECAL PORTABLE X-RAY UNIT

Model Number SM 40HF BDC

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

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

Event Date 10/06/2017

Event Type  Injury  

Event Description

X-ray tech was setting up a rad pro portable x-ray unit for a 72" sid chest x-ray when the collimator became detached from its mounting ring.It did not come in contact with the pt.Clinical engineering (ce) investigated and discovered the four mounting screws were loosening during normal usage.Ce applied loctite to these screws and made subsequent inspection of these screws for several days afterwards - no loosening has occurred.

• Brand Name: PORTABLE X-RAY UNIT
• Type of Device: PORTABLE X-RAY UNIT
• Manufacturer (Section D): SEDECAL
• MDR Report Key: 7027726
• MDR Text Key: 92076839
• Report Number: MW5073318
• Device Sequence Number: 1
• Product Code: IZL
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SM 40HF BDC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention