MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG UNKNOWN; N/A

Device Problem Unintended System Motion (1430)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure and use of a baxter surgical table and an additional unknown device with an adaptor/head positioner, the unknown device was noted to have led to unintended head movement of the patient due to the side with the sensor being broken.There was no injury or surgical delay alleged from the event.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

Inspection of the device is pending and results will be provided by a final report.

• Brand Name: UNKNOWN
• Type of Device: N/A
• 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: 16495483
• MDR Text Key: 310869181
• Report Number: 3007143268-2023-00003
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1