MAUDE Adverse Event Report: MAQUET GMBH SEAT PLATE EXTENSION, SFC-PAD, EU; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 116055BC

Device Problems Use of Device Problem (1670); Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Pain (1994); Ulcer (2274)

Event Date 01/17/2024

Event Type  Injury  

Event Description

On 17th january 2024 getinge became aware of an issue with one of our mobile tables - 720001b2 - meera eu with auto drive.As it was stated and confirmed with the photographic evidence, pressure injury on the lower back and buttocks of the patient was found following the procedure.The provided information suggests that the patient was positioned partially over the edge of the operating table and the staff did not use the recommended seat plate extension.Initially, it was confirmed there were no open wounds and no medical intervention was necessary.On 24th january 2024, additional details regarding surgery and patient's injury were received.As it was stated, the patient's skin was intact before surgery (genital reassignment mtf) and the injury was discovered during repositioning of the patient.According to provided information, the patient's injury was assessed as decubitus ulcer grade 2.The patient is experiencing pain, special positioning in bed is required and there is restriction of mobility.Additionally, hydrocolloid dressings are being applied on the wound.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

On 17th january 2024 getinge became aware of an issue with one of our accessories 116055bc - seat plate extension, sfc-pad, eu used with 720001b2 - meera eu with auto drive.As it was stated and confirmed with the photographic evidence, pressure injury on the lower back and buttocks of the patient was found following the procedure.The provided information suggests that the patient was positioned partially over the edge of the operating table and the staff did not use the recommended seat plate extension.Initially, it was confirmed there were no open wounds and no medical intervention was necessary.On 24th january 2024, additional details regarding surgery and patient's injury were received.As it was stated, the patient's skin was intact before surgery (genital reassignment mtf) and the injury was discovered during repositioning of the patient.According to provided information, the patient's injury was assessed as decubitus ulcer grade 2.The patient is experiencing pain, special positioning in bed is required and there is restriction of mobility.Additionally, hydrocolloid dressings are being applied on the wound.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.Previous b5 describe event or problem: on 17th january 2024 getinge became aware of an issue with one of our mobile tables - 720001b2 - meera eu with auto drive.As it was stated and confirmed with the photographic evidence, pressure injury on the lower back and buttocks of the patient was found following the procedure.The provided information suggests that the patient was positioned partially over the edge of the operating table and the staff did not use the recommended seat plate extension.Initially, it was confirmed there were no open wounds and no medical intervention was necessary.On 24th january 2024, additional details regarding surgery and patient's injury were received.As it was stated, the patient's skin was intact before surgery (genital reassignment mtf) and the injury was discovered during repositioning of the patient.According to provided information, the patient's injury was assessed as decubitus ulcer grade 2.The patient is experiencing pain, special positioning in bed is required and there is restriction of mobility.Additionally, hydrocolloid dressings are being applied on the wound.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.Corrected b5 describe event or problem: on 17th january 2024 getinge became aware of an issue with one of our accessories 116055bc - seat plate extension, sfc-pad, eu used with 720001b2 - meera eu with auto drive.As it was stated and confirmed with the photographic evidence, pressure injury on the lower back and buttocks of the patient was found following the procedure.The provided information suggests that the patient was positioned partially over the edge of the operating table and the staff did not use the recommended seat plate extension.Initially, it was confirmed there were no open wounds and no medical intervention was necessary.On 24th january 2024, additional details regarding surgery and patient's injury were received.As it was stated, the patient's skin was intact before surgery (genital reassignment mtf) and the injury was discovered during repositioning of the patient.According to provided information, the patient's injury was assessed as decubitus ulcer grade 2.The patient is experiencing pain, special positioning in bed is required and there is restriction of mobility.Additionally, hydrocolloid dressings are being applied on the wound.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.Previous d1 brand name: meera eu with auto drive, corrected d1 brand name: seat plate extension, sfc-pad, eu.Previous d2 common device name: fqo table, operating-room, ac-powered, corrected d2 common device name: bwn table and attachments, operating-room.Previous d4 version or model #: 720001b2, corrected d4 version or model #: 116055bc.Previous d4 catalog #: 720001b2, corrected d4 catalog #: 116055bc.

• Brand Name: SEAT PLATE EXTENSION, SFC-PAD, 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: 18579824
• MDR Text Key: 333730924
• Report Number: 3013876692-2024-00006
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 116055BC
• Device Catalogue Number: 116055BC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2024
• Distributor Facility Aware Date: 02/06/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 720001B2 MEERA EU WITH AUTO DRIVE
• Patient Outcome(s): Required Intervention