MAUDE Adverse Event Report: MAQUET GMBH EXTENSION DEVICE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 141901HC

Device Problems Detachment of Device or Device Component (2907); Device Handling Problem (3265)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with 141901hc - extension device used with 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, during emergency surgery, the anesthetized patient's leg was positioned on 141901hc - extension device.When the staff started to pull the patient's leg, the right adapter for the extension device detached.Consequently, the patient's waist was not supported and was immediately lifted by the staff.The device was removed due to the incident and the operating table was replaced in order to complete procedure.After surgery, x-ray of the patient's waist was performed and it was confirmed there was no injury to the bone.We decided to report the issue based on the potential for serious injury if the situation, namely the detachment of the adapter leading to change in the patient's position, was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with 141901hc - extension device used with 141904f0 - adapter, pair and 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, during emergency surgery, the anesthetized patient's leg was positioned on the extension device.When the staff started to pull the patient's leg, the right adapter for the extension device detached.Consequently, the patient's waist was not supported and was immediately lifted by the staff.The device was removed due to the incident and the operating table was replaced in order to complete the procedure.The issue led to a delay of approximately 10 minutes.After surgery, an x-ray of the patient's waist was performed and it was confirmed there was no injury to the bone.We decided to report the issue based on the potential for serious injury if the situation, namely the detachment of the adapter leading to a change in the patient's position and delay resulting in prolonged anesthesia time, was to reoccur.The affected extension device, adapter and the alphamaxx mobile table involved in the reported issue were evaluated by the getinge service technician.The technician placed a leveler on the extension device towing adapter and confirmed that it was leveled.There were no bends or damages of the device.No malfunction with the extension device and mobile table was found.To confirm that the devices are working properly with each other, the technician connected the extension device to the mobile table.The devices worked according to specifications.After consultation with subject matter expert from the manufacturing site it was established that the most possible cause of the reported situation is that the user did not attach the adapter properly to the table.It was also pointed out that from the mechanical point of view if the round interface is properly attached, it will not slip out of the interface if it is not damaged and it is not possible that the adapter detached from the table if somebody or something opened the closing handle of the adapter during or before pulling the patient¿s leg.In the user manual (ifu 1419.01 en 32, page 19) the user is informed that the products / accessories not attached properly may loosen and cause injuries and that before use the user should ensure that all products are mounted correctly.The user should ensure that the securing elements (handle screws, catches, levers, etc.) are closed and firmly tightened and that moving parts are correctly secured.Additionally, after every adjustment procedure the user should ensure that all locking elements are closed (ifu 1419.01 en 32, page 20).The information about proper attachment and removing the extension device is contained in the user manual (ifu 1419.01 en 32, pages 31-48).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 malfunction of devices was found, it was considered that the getinge device was up to the specification.The root cause for the reported issue is a user error related to the incorrect attachment of the extension device to the mobile table.In the past there was one similar customer product complaint related to same scenario as investigated here, therefore the failure ratio is (b)(4) % for the issue investigated herein regarding the extension device.The failure ratio for the configuration of the extension device, adapter and the alphamaxx mobile tables is (b)(4) %.We currently do not have any information that would warrant further action towards the 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.

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.The correction of b5 describe event or problem field deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on (b)(6) 2023 getinge became aware of an issue with 141901hc - extension device used with 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, during emergency surgery, the anesthetized patient's leg was positioned on 141901hc - extension device.When the staff started to pull the patient's leg, the right adapter for the extension device detached.Consequently, the patient's waist was not supported and was immediately lifted by the staff.The device was removed due to the incident and the operating table was replaced in order to complete procedure.After surgery, x-ray of the patient's waist was performed and it was confirmed there was no injury to the bone.We decided to report the issue based on the potential for serious injury if the situation, namely the detachment of the adapter leading to change in the patient's position, was to reoccur.Corrected b5 describe event or problem: on (b)(6) 2023, getinge became aware of an issue with 141901hc - extension device used with 141904f0 - adapter, pair and 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, during emergency surgery, the anesthetized patient's leg was positioned on 141901hc - extension device.When the staff started to pull the patient's leg, the right adapter for the extension device detached.Consequently, the patient's waist was not supported and was immediately lifted by the staff.The device was removed due to the incident and the operating table was replaced in order to complete the procedure.The issue led to a delay of approximately 10 minutes.After surgery, an x-ray of the patient's waist was performed and it was confirmed there was no injury to the bone.We decided to report the issue based on the potential for serious injury if the situation, namely the detachment of the adapter leading to a change in the patient's position and delay resulting in prolonged anesthesia time, was to reoccur.

Event Description

On (b)(6) 2023, getinge became aware of an issue with 141901hc - extension device used with 141904f0 - adapter, pair and 113312b3 - alphamaxx motor drive unit, eu side rail.As it was stated, during emergency surgery, the anesthetized patient's leg was positioned on 141901hc - extension device.When the staff started to pull the patient's leg, the right adapter for the extension device detached.Consequently, the patient's waist was not supported and was immediately lifted by the staff.The device was removed due to the incident and the operating table was replaced in order to complete the procedure.The issue led to a delay of approximately 10 minutes.After surgery, an x-ray of the patient's waist was performed and it was confirmed there was no injury to the bone.We decided to report the issue based on the potential for serious injury if the situation, namely the detachment of the adapter leading to a change in the patient's position and delay resulting in prolonged anesthesia time, was to reoccur.

• Brand Name: EXTENSION DEVICE
• 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: 16596309
• MDR Text Key: 311838809
• Report Number: 8010652-2023-00024
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2023

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: 141901HC
• Device Catalogue Number: 141901HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 04/18/2023; 05/22/2023
• Supplement Dates FDA Received: 05/10/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 113312B3 - ALPHAMAXX MOTOR DRIVE UNIT; 141904F0 - ADAPTER