MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CARESCAPE CENTRAL STATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number V2 INTEGRATED MAI 700

Device Problems No Display/Image (1183); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Central patient monitoring station went dark and contacted biomedical engineering.A biomedical engineering technician verified the device was plugged in and turned it off and on again.There was a popping noise similar to previous failures, so the device was removed from service and upon further investigation, an issue with the internal power supply assembly component was identified.The patients were watched on a different central station until a replacement was set up.

• Brand Name: CARESCAPE CENTRAL STATION
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 west tower avenue; milwaukee WI 53223
• MDR Report Key: 12750599
• MDR Text Key: 280095613
• Report Number: 12750599
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V2 INTEGRATED MAI 700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1