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

Model Number	4080100
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
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 hydraulic unit after some time disengages (loss of pressure) without table recognizing its unlocked.Staff then have to unlock the table so software will know its unlocked (without any effect because brakes are already unlocked) and then lock it again.Additionally it was confirmed that all four stamps released during procedures and then the table moves when someone is leaning on it.No harm or significant impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
During on-site investigation the field service technician identified an issue with the hydraulic unit of the operating table.The hydraulic unit is responsible for the floor locks of the device.After 4-6 hours the locked device will become unlocked by itself which allows the operating table to be no longer fixed and to move on the floor.This hydraulic unit was exchanged.An investigation by the supplier of the hydraulic unit identified that during the manufacturing process not all air was removed from the system.The supplier changed the manufacturing process to ensure that all air is removed.Based on this, no further actions are required.
Event or Problem Description
Customer reported that hydraulic unit after some time disengages (loss of pressure) without table recognizing its unlocked.Staff then have to unlock the table so software will know its unlocked (without any effect because brakes are already unlocked) and then lock it again.Additionally it was confirmed that all four stamps released during procedures and then the table moves when someone is leaning on it.No harm or significant impact to the surgical procedure was reported.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 47006 ; GM 47006
• MDR Report Key: 16618636
• Report Number: 3007143268-2023-00005
• Device Sequence Number: 12285304
• Product Code: GDC
• UDI-Device Identifier: 00887761979390
• UDI-Public: 00887761979390
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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): 06/01/2023

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: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 06/01/2023
• 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