MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG PST 500; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	4080100
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Customer reported that table has no functions.Displaying error 62.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
During investigation the failure of the not working operating table could be confirmed.It was identified that the base controller (main electronical unit) had an issue.The base controller was exchanged, and the device was working as intended.No systematic issue was identified with the base controller.Based on this, no further action is required.
Event or Problem Description
Customer reported that table has no functions.Displaying error 62.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: PST 500
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 19951035
• Report Number: 3007143268-2024-00034
• Device Sequence Number: 12986221
• Product Code: GDC
• UDI-Device Identifier: 00887761979390
• UDI-Public: 887761979390
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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 Model Number: 4080100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2024
• Supplement Date Received by Manufacturer: 07/21/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown