MAUDE Adverse Event Report: IHB OPERATIONS SKYTRON ERGON 3 BOOM

Model Number ERGON 3

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Skytron is investigating to establish a root cause.

Event Description

Skytron received a complaint alleging the ground fault circuit interruptor outlets on booms are tripping causing an interruption of power supply in multiple rooms.

• Brand Name: SKYTRON ERGON 3 BOOM
• Type of Device: BOOM
• Manufacturer (Section D): IHB OPERATIONS; floresstraat 52; zwolle, overijssel 8022 ad ; NL
• MDR Report Key: 11791705
• MDR Text Key: 252159596
• Report Number: 1825014-2021-00011
• 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: 05/07/2021

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: No Information
• Device Model Number: ERGON 3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2021
• Distributor Facility Aware Date: 04/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1