MAUDE Adverse Event Report: MAQUET GMBH BASIC TABLE TOP; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	118010A0
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 event site name: (b)(6).The full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.
Event or Problem Description
Getinge became aware of an issue with one of our tabletops ¿ 118010a0 basis tabletop, individual configuration.During a 4-hour cardiac surgery, the patient was placed in a supine position, and a stage ii pressure sore developed on the buttocks.There was no malfunction of the tabletop or table pad, the injury resulted from prolonged ischemia time and the patient¿s general condition.The injury was described as significant, requiring additional treatment, extended hospital stay, and possibly surgical intervention.We decided to report the issue due to the serious injury of the patient.
Event or Problem Description
Getinge became aware of an issue with one of our tabletops ¿ 118010a0 basis tabletop, individual configuration.During a 4-hour cardiac surgery, the patient was placed in a supine position, and a stage ii pressure sore developed on the buttocks.According to the provided information, the injury resulted from prolonged ischemia time and the patient¿s general condition.The injury was described as significant, requiring additional treatment, extended hospital stay, and possibly surgical intervention.We decided to report the issue due to the serious injury of the patient.
Additional Manufacturer Narrative
The correction of b5 describe event and problem and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: getinge became aware of an issue with one of our table tops ¿ 118010a0 basis table top, individual configuration.During a 4-hour cardiac surgery, the patient was placed in a supine position, and a stage ii pressure sore developed on the buttocks.There was no malfunction of the table top or table pad, the injury resulted from prolonged ischemia time and the patient¿s general condition.The injury was described as significant, requiring additional treatment, extended hospital stay, and possibly surgical intervention.We decided to report the issue due to the serious injury of the patient.Corrected b5 describe event and problem: getinge became aware of an issue with one of our table tops ¿ 118010a0 basis table top, individual configuration.During a 4-hour cardiac surgery, the patient was placed in a supine position, and a stage ii pressure sore developed on the buttocks.According to the provided information, the injury resulted from prolonged ischemia time and the patient¿s general condition.The injury was described as significant, requiring additional treatment, extended hospital stay, and possibly surgical intervention.We decided to report the issue due to the serious injury of the patient.Previous h6 medical device ¿ problem code: adverse event without identified device or use problem 2993.Corrected h6 medical device ¿ problem code: patient device interaction problem 4001.Getinge became aware of an issue with one of our tabletops ¿ 118010a0 basis tabletop, individual configuration.During a 4-hour cardiac surgery, the patient was placed in a supine position, and a stage ii pressure sore developed on the buttocks.According to the provided information, the injury resulted from prolonged ischemia time and the patient¿s general condition.The injury was described as significant, requiring additional treatment, extended hospital stay, and possibly surgical intervention.We decided to report the issue due to the serious injury of the patient.Based on the information provided by the customer, no defect of the table top or pad was found.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As no relevant malfunction with the device was reported, it has been assessed that the getinge device was up to the specification.In the instructions for use, the user is warned that improper positioning can be detrimental to patient health (e.G.Causing bedsores).The user is advised to position the patient correctly and maintain continuous observation (ga 1180.01 rev.16, page 21).In summary, this issue was caused by the patient¿s general condition.Therefore, the most probable root cause for this issue is user¿operational context.We currently do not have any information that would warrant further action regarding device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.

• Brand Name: BASIC TABLE TOP
• Common Device Name: TABLE, OPERATING-ROOM, AC-POWERED
• 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: 22058739
• Report Number: 8010652-2025-0000021
• Device Sequence Number: 8478150
• Product Code: FQO
• UDI-Device Identifier: 04046768031593
• UDI-Public: (01)04046768031593
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 118010A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown