MAUDE Adverse Event Report: MAQUET GMBH OR-TABLE MOBILE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113101C0

Device Problem Unintended Movement (3026)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our mobile tables ¿ 113101c0 or-table mobile.As it was stated, the unintended movement of the table had occurred before surgery started.The anesthetized patient weighing more than 120 kg was on the table at the time of the incident.The patient was transferred to another table which resulted in a delay of surgery.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

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) 2022 getinge became aware of an issue with one of our mobile tables ¿ 113101c0 or-table mobile.As it was stated, the unintended movement of the table had occurred before surgery started.The anesthetized patient weighing more than 120 kg was on the table at the time of the incident.The patient was transferred to another table which resulted in a delay of surgery.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.Corrected b5 describe event or problem: on (b)(6) 2022 getinge became aware of an issue with one of our mobile tables ¿ 113101c0 or-table mobile.As it was stated, the unintended down movement of the table top had occurred before surgery started.The anesthetized patient weighing more than 120 kg was on the table at the time of the incident.The patient was transferred to another table which resulted in a delay of surgery.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our mobile tables ¿ 113101c0 or-table mobile.As it was stated, the unintended down movement of the table top had occurred before surgery started.The anesthetized patient weighing more than 120 kg was on the table at the time of the incident.The patient was transferred to another table which resulted in a delay of surgery.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with the 113101c0 or-table mobile.The unintended movement of the table had occurred before surgery started.The anesthetized patient weighing more than 120 kg was on the table at the time of the incident and needed to be transferred to another table, which resulted in a delay of surgery.There was no injury of the patient reported, however, we decided to report the issue as a delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.The affected or-table mobile was investigated by a getinge service technician.The technician found the internal leakage of the oil from the hydraulic cylinder due to deteriorated rubber seal and a damaged double check valve.The affected table was manufactured at least 27 years before the incident took place and review of our company database showed no previous complaints registered for this device with the same failure mode.Additionally, this particular device range has been discontinued in the production since 1995 and the end of service for the installed base took place in 2005.The root cause for the damaged double check valve and hydraulic cylinder failure, which led to the oil leakage for the or-table mobile was established as wearing of the parts related to the prolonged usage.The customer did not approve the quotation and the affected parts were not replaced.The affected mobile table will be scrapped and replaced by the new device.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, thus was also directly involved with the reported incident.As the malfunction of the hydraulic cylinder and the double check valve was found, it was considered that the getinge device was not up to the specification.There were no similar complaints found related to this issue investigated here, therefore it appears to be isolated to this single occurrence when considering this particular device range, thus the investigated issue is considered an isolated case.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.

• Brand Name: OR-TABLE MOBILE
• Type of Device: 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: 15788105
• MDR Text Key: 307594740
• Report Number: 8010652-2022-00038
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 113101C0
• Device Catalogue Number: 113101C0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1