MAUDE Adverse Event Report: DAI-ICHI SHOMEI CO. LTD SKYTRON; LFS

Model Number B2-610-12

Device Problems Break (1069); Material Separation (1562); Ejection Problem (4009)

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

Event Type  Injury  

Event Description

At the end of a case, while the patient was still in the room, the spring guide rod on an lfs monitor bracket sheared off and flew ~15-20 feet and stuck into the far wall near the ceiling.The spring also ejected and flew into the room.There was a patient on the table at the time, and three or staff sitting next to the table.The projectile flew just a couple feet directly over all of their heads and the patient's feet.The per the or staff, the monitor was recently set in the vertical position.It had been sitting for a few minutes with nobody touching it when it suddenly broke.They told us that they thought the monitor tipped up, then fell back down.

• Brand Name: SKYTRON
• Type of Device: LFS
• Manufacturer (Section D): DAI-ICHI SHOMEI CO. LTD; 1-32-26 sakashita itabashi-ku; tokyo, japan 174-0 043; JA 174-0043
• MDR Report Key: 10454542
• MDR Text Key: 205163476
• Report Number: 1825014-2020-00009
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: B2-610-12
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2020
• Distributor Facility Aware Date: 07/31/2020
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1