MAUDE Adverse Event Report: MAQUET GMBH BACK PLATE F. SHOULDER OPERATIONS SFC,EU; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100721B0

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).

Event Description

On 11th march 2024 getinge became aware of an issue with one of our accessories ¿ 100721b0 - back plate f.Shoulder operations sfc, eu used with 143302b0 - yuno 2 eu with autodrive.As it was stated, the back plate unfastened from the table mounting lock what occurred during the procedure.The situation allegedly took place when the patient was waking up and began to fidget.The anesthesia nurse managed to catch the patient and prevent the patient's fall.Following the incident, the patient was transferred to another bed.According to information provided by the service technician, the defect could have occurred due to excessive load on the device.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the detachment of the back plate which could potentially result in the patient fall, was to reoccur.

• Brand Name: BACK PLATE F. SHOULDER OPERATIONS SFC,EU
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 18912637
• MDR Text Key: 337771699
• Report Number: 8010652-2024-00042
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

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 Operator: Health Professional
• Device Model Number: 100721B0
• Device Catalogue Number: 100721B0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 143302B0 - YUNO 2 EU WITH AUTODRIVE