MAUDE Adverse Event Report: IHB SKYTRON; 32S LOWER SPRING ARM

Device Problems Component Falling (1105); Installation-Related Problem (2965)

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

Event Type  Injury  

Event Description

The bottom access cover from a skytron boom fell.No patient injuries were reported.From the details provided the bottom cover was ran into other equipment in the operating room causing it to fall.It appears that this was installed incorrectly.Additionally it appears that this was installed incorrectly.Per the skytron installation manual when installed correctly there are two set screws that hold the cover in place to prevent it from falling.

• Brand Name: SKYTRON
• Type of Device: 32S LOWER SPRING ARM
• Manufacturer (Section D): IHB; po box 79; 8000 ab zwolle; zwolle, netherlands ; NL
• MDR Report Key: 6827879
• MDR Text Key: 83907621
• Report Number: 1825014-2017-00003
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2017
• Distributor Facility Aware Date: 05/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention