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

Model Number 116001A0

Device Problems Circuit Failure (1089); Corroded (1131)

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

Event Date 04/19/2023

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 20th april 2023 getinge became aware of an issue with one of our column ¿ 116001a0 - otesus or table column, stationary.During the surgery (incisional hernia with direct suture) the column could no longer be raised or lowered, which resulted in 30 minutes of delay in treatment of anesthetized patient.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.

Manufacturer Narrative

Getinge became aware of an issue with one of our table columns ¿ 116001a0 - otesus or table column, stationary.During the surgery (incisional hernia with direct suture) the column could no longer be raised or lowered, even by using external universal remote control (100925a0 - universal remote control).The event resulted in 30 minutes of delay in the treatment of anesthetized patient.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.The evaluation of the affected column performed by getinge technician revealed corrosion on the contacts in the accessory socket (part number 2235464) and missing hinged covers (part number 2235974).According to the technician, the corrosion was causing a short circuit which disrupted the column's communication channel.As the hinged covers were missing, the cleaning agent must have penetrated into the device socket, which in consequence caused the contact's corrosion.In the user manual (ifu 1160.01 en 14, page 107) the user is informed that to ensure correct operation, it is necessary to have visual and functional inspections performed by a trained person prior to each use.Furthermore, the user is instructed to always ensure that no liquids can penetrate any live parts (ifu 1160.01 en 14, page 101).The technician provided information that the user was instructed to always pay attention to the hinged cover.With the information gathered as a result of the root cause analysis performed, it can be concluded that the reported event was caused by user error related to following the instruction given in the user manual.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment and was also directly involved with the reported incident.As the corrosion at the socket was found it was considered that the getinge device was not up to specification.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 b3 date of event and b5 describe event or problem field deems required due to the update of the awareness date.Additionally, the correction of h6 health effect ¿ impact codes field also deems required.This is based on the internal evaluation.Previous b3 date of event: 04/20/2023.Corrected b3 date of event: 04/19/2023.Previous b5 describe event or problem: on 20th april 2023 getinge became aware of an issue with one of our column ¿ 116001a0 - otesus or table column, stationary.During the surgery (incisional hernia with direct suture) the column could no longer be raised or lowered, which resulted in 30 minutes of delay in treatment of anesthetized patient.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: on 19th april 2023, getinge became aware of an issue with one of our columns ¿ 116001a0 - otesus or table column, stationary.During the surgery (incisional hernia with direct suture) the column could no longer be raised or lowered, even by using external remote control (100925a0 - universal remote control).The event resulted in 30 minutes of delay in the treatment of anesthetized patient.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Previous h6 health effect ¿ impact codes: no health consequences or impact|||2199 corrected h6 health effect ¿ impact codes: surgical intervention|prolonged surgery||4632.

Event Description

On 19th april 2023, getinge became aware of an issue with one of our columns ¿ 116001a0 - otesus or table column, stationary.During the surgery (incisional hernia with direct suture) the column could no longer be raised or lowered, even by using external remote control (100925a0 - universal remote control).The event resulted in 30 minutes of delay in the treatment of anesthetized patient.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.

• Brand Name: OTESUS OR TABLE COLUMN, STATIONARY
• 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: 16794071
• MDR Text Key: 313806549
• Report Number: 8010652-2023-00037
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 116001A0
• Device Catalogue Number: 116001A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 100925A0 - UNIVERSAL REMOTE CONTROL.