MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG HEAD SECTION 530 DOUBLE JOINT T; OPERATING/EXAMINATION/ TREATMENT TABLE HEADREST

Model Number 1397893

Device Problems Mechanical Problem (1384); Unintended Movement (3026); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation of this allegation is still ongoing.The device is being returned for further investigations and a follow-up report will be submitted once a final resolution has been reached.

Event Description

The customer alleged, the head section of the operating table tilted/ dropped down during a surgical procedure.No injury reported, the anesthetized patient was almost extubated.

Manufacturer Narrative

The affected head section was investigated by trumpf medical/hillrom.An internal part was broken which allowed the head section to drop and no longer stay at the set position.During the device inspection it was discovered, that the head section had a bent side rail and some screws were not according to our manufacturing specifications.It was concluded an external overload or collision damaged the head section and was the root cause for the broken internal part.It is not possible for this type of overload or collision to occur when the instructions for use of the product are followed.Also, the device seems to be repaired by a third party that is not under control of trumpf medical/hillrom.No records for this product exist within trumpf medical/hillrom device history for any repair or service event.No device problem or other deviation from the specifications were identified.Based on this information, no further action is required.

• Brand Name: HEAD SECTION 530 DOUBLE JOINT T
• Type of Device: OPERATING/EXAMINATION/ TREATMENT TABLE HEADREST
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss strasse 7-9; saalfeld, 07318 ; GM 07318
• MDR Report Key: 9862907
• MDR Text Key: 189457148
• Report Number: 3007143268-2020-00003
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1397893
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1