MAUDE Adverse Event Report: MAQUET GMBH LEG PLATES, PAIR; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 115063DC

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 17th march 2023 getinge became aware of an issue with one of our accessories ¿ 115063dc leg plates, pair.As it was stated, the leg plate broke off during transfer of the patient from bed to operating table.The patient was not yet anesthetized.Following the incident, the patient was immediately transferred back to bed and the procedure (caesarean section) was completed with slight delay after operating table was changed.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely fast unintended movement of leg plate which could lead to change in the patient's position, was to reoccur.

Event Description

On 17th march 2023, getinge became aware of an issue with one of our accessories ¿ the 115063dc leg plates, pair used with one of our modular universal table top.According to the initially provided information, the leg plate broke off during the transfer of the patient from the bed to the operating table.As it was clarified later on, only the cushion detached from the leg plate.The patient was not yet anesthetized.Following the incident, the patient was immediately transferred back to bed and the procedure (cesarean section) was completed with a slight delay after the operating table was changed.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely detachment of the cushion of the leg plate during the transfer of the patient which could lead to a change in the patient's position, was to reoccur.

Manufacturer Narrative

Getinge became aware of an issue with 115063dc leg plates, pair used with one of our modular universal table top.According to the initially provided information, the leg plate broke off during transfer of the patient from bed to operating table.As it was clarified later on, only the cushion detached from the leg plate.The patient was not yet anesthetized.Following the incident, the patient was immediately transferred back to bed and the procedure (cesarean section) was completed with a slight delay after the operating table was changed.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 cushion of the leg plate during transfer of the patient which could lead to a change in the patient's position, was to reoccur.The affected leg plates were evaluated by the getinge technician.The technician confirmed the malfunction of the leg plate and stated that the screw connection (part number 11071649) was worn, probably due to age as the device was manufactured in 2003.Due to a worn screw connection, the cushion of the leg plate detached.In the user manual ((b)(6)4, page 2) the user is warned to not use worn or damaged accessories.The affected device was replaced with new leg plates.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 the malfunction of the screw connection was found, it was considered that the getinge device was not up to specification.The root cause for the reported issue is concluded as wear of the screw related to the prolonged usage that caused a malfunction of the leg plate cushion connection and consequently led to its detachment.The trend review revealed that the failure ratio for the leg plates is (b)(4)% for the issue investigated herein.The failure ratio for configuration used in this particular incident 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.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 17th march 2023 getinge became aware of an issue with one of our accessories ¿ (b)(6) leg plates, pair.As it was stated, the leg plate broke off during transfer of the patient from bed to operating table.The patient was not yet anesthetized.Following the incident, the patient was immediately transferred back to bed and the procedure (caesarean section) was completed with slight delay after operating table was changed.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely fast unintended movement of leg plate which could lead to change in the patient's position, was to reoccur.Corrected b5 describe event or problem: on 17th march 2023, getinge became aware of an issue with one of our accessories ¿ the (b)(6) leg plates, pair used with one of our modular universal table top.According to the initially provided information, the leg plate broke off during the transfer of the patient from the bed to the operating table.As it was clarified later on, only the cushion detached from the leg plate.The patient was not yet anesthetized.Following the incident, the patient was immediately transferred back to bed and the procedure (cesarean section) was completed with a slight delay after the operating table was changed.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely detachment of the cushion of the leg plate during the transfer of the patient which could lead to a change in the patient's position, was to reoccur.Previous h6 medical device ¿ problem code: mechanical problem|unintended movement||3026 corrected h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907.

• Brand Name: LEG PLATES, PAIR
• 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: 16655321
• MDR Text Key: 313417006
• Report Number: 8010652-2023-00029
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 115063DC
• Device Catalogue Number: 115063DC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2003
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MODULAR UNIVERSAL TABLE TOP