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

Model Number 141901HC

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6) hosp.Univ.H3 other text : device not returned to manufacturer.

Event Description

On (b)(6) 2024 getinge became aware of an issue with one of our devices - 141901hc - extension device (coded) used with 113312b1 - alphamaxx sfc-pads, eu-side rails.As it was stated, the patient was placed in a supine position on the operating table and was locally anesthetized.Before starting the surgery the staff noticed that the device was not well anchored.The fixation was corrected and the surgery was continued.The coupling of extension device with the alphamax table was verified and no fault was found.The operation was repeated several times and the result was satisfactory with respect to the proper functioning and coupling of 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 device being incorrectly attached while the patient was on the table, which could result in unintended movement and cause the patient's legs to fall downwards, was to reoccur.

Event Description

On 27th february 2024 getinge became aware of an issue with one of our devices - 141901hc - extension device (coded) used with 113312b1 - alphamaxx sfc-pads, eu-side rails.As it was stated, the patient was placed in a supine position on the operating table and was locally anesthetized.Before starting the surgery, the staff noticed that the device was not well anchored.The fixation was corrected and the surgery was continued.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the device being incorrectly attached while the patient was on the table, which could result in unintended movement and cause the patient's legs to fall downwards, was to reoccur.

Manufacturer Narrative

Initial reporter: hospital maintenance department.Getinge became aware of an issue with one of our devices - 141901hc - extension device (coded) used with 113312b1 - alphamaxx sfc-pads, eu-side rails.As it was stated, the patient was placed in a supine position on the operating table and was locally anesthetized.Before starting the surgery, the staff noticed that the device was not well anchored.The fixation was corrected and the surgery was continued.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the device being incorrectly attached while the patient was on the table, which could result in unintended movement and cause the patient's legs to fall downwards, was to reoccur.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment and was directly involved with the reported incident.As no malfunction of the device was confirmed, it has been assessed that the getinge device did not fail to meet its specifications.A review of the received customer product complaints revealed that in the past the issues did not lead to serious injury to the user.Comparing the number of complained devices to the number of 141901 extension devices - on the market we can conclude the failure ratio is (b)(4) for the issue investigated herein.Comparing the number of complained devices to the number of 141901 extension devices and all versions of the 113312 alphamaxx mobile operating on the market we can conclude the failure ratio for configuration is (b)(4) for the issue investigated herein.The affected device has been evaluated by the getinge service technician.The coupling of extension device with the alphamaxx table was verified and no fault was found.The operation was repeated several times and the result was satisfactory with respect to the proper functioning and coupling of the device.The user has been informed about the proper locking and unlocking procedure for using this device.In the instructions for use (ga 1419.01 en 25, page 12), the user is warned that the products / accessories not attached properly may loosen and cause injuries.The user shall always ensure that all locking elements (offset lever, setting clamps, catches etc.) of the product / accessory are closed and movable parts are fixed properly.The user shall check locking after every adjustment procedure.The user is also informed (ga 1419.01 en 25, page 13), that if locking elements (offset levers, handle screws, locking mechanisms etc.) are opened, the clamps are released and the product can be moved.Before opening the locking elements, the user shall hold the individual parts securely.The user shall ensure that all locking elements are closed after each adjustment procedure.Based on the information provided by the ssu it has been evident that the user utilized the device disregarding the safety notes from the instructions for use.In summary and as a result of the performed root cause evaluation, it was concluded that the investigated issue was most likely caused by the user error.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.The correction of b5 describe event or problem, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain, h4 device manufacture date, h6 component codes fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 27th february 2024 getinge became aware of an issue with one of our devices - 141901hc - extension device (coded) used with 113312b1 - alphamaxx sfc-pads, eu-side rails.As it was stated, the patient was placed in a supine position on the operating table and was locally anesthetized.Before starting the surgery the staff noticed that the device was not well anchored.The fixation was corrected and the surgery was continued.The coupling of extension device with the alphamax table was verified and no fault was found.The operation was repeated several times and the result was satisfactory with respect to the proper functioning and coupling of 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 device being incorrectly attached while the patient was on the table, which could result in unintended movement and cause the patient's legs to fall downwards, was to reoccur.Corrected b5 describe event or problem: on 27th february 2024 getinge became aware of an issue with one of our devices - 141901hc - extension device (coded) used with 113312b1 - alphamaxx sfc-pads, eu-side rails.As it was stated, the patient was placed in a supine position on the operating table and was locally anesthetized.Before starting the surgery, the staff noticed that the device was not well anchored.The fixation was corrected and the surgery was continued.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the device being incorrectly attached while the patient was on the table, which could result in unintended movement and cause the patient's legs to fall downwards, was to reoccur.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Previous h3c if other provide code - explain: device not returned to manufacturer.Previous h4 device manufacture date: 09/01/2015.Corrected h4 device manufacture date: 09/16/2014.Previous h6 component codes: mechanical|fastener|screw|568 mechanical|plate||907.Corrected h6 component codes: safety|locking mechanism||3083.

• Brand Name: EXTENSION DEVICE (CODED)
• 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: 18835921
• MDR Text Key: 337309365
• Report Number: 8010652-2024-00031
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 03/05/2024

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: 141901HC
• Device Catalogue Number: 141901HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 113312B1 - ALPHAMAXX SFC-PADS, EU-SIDE RAILS