MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, INC. REVOLUTION; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number REVOLUTION HD 2000

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2021

Event Type  malfunction  

Event Description

Mfg was called in to check the status of the a1 panel to check battery and charger type for battery replacement.This was in response to a previous a1 panel error that occurred in our mri room.The a1 panel has a battery that keeps the breaker engaged during a power flicker to ensure the room stays energized.This will help when performing generator tests and the power transitions from facility power to generator power.What was identified is if the battery for the a1 panel is not replaced, it will not hold the charge and not allow the breaker to say energized and will cause the room to go down during a generator test or power outage.The a1 panel has been an overlooked item that is integral to the operation of these rooms (mri and ct).Hospital service notes: service notes (customer visible): i found a breaker was not resetting, i had building engineering reset the breaker and the room then was powered on.Manufacturer response for a1 panel check, (brand not provided) (per site reporter).Mfr performed the following notes: problem found: evaluating system's a1 panel for old battery and charger, and assisting electricians with procurement of proper upgrades or replacements.Action taken: provided electricians with charger and battery.Electricians installed these items in a1 panel.Verification details: operational checkout.

• Brand Name: REVOLUTION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, INC.; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 12614766
• MDR Text Key: 275912690
• Report Number: 12614766
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REVOLUTION HD 2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1