MAUDE Adverse Event Report: MAQUET GMBH ALPHAMAXX SFC-PADS, EU-SIDE RAILS; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113312B1

Device Problem Positioning Problem (3009)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Event site telephone: (b)(6).Device not returned to manufacturer.

Event Description

On 22nd november, 2022 getinge became aware of an issue with one of our mobile tables: 113312b1 - alphamaxx sfc-pads, eu-side rails.As it was stated, the table stopped working during the surgery on the anesthetized patient.According to information provided by the customer, the staff tried to operate the table with 2 different handsets and override panel.It was reported that the override panel did not work at first, however, started to work on the second attempt.The surgery was continued and was finished with a delay of around 2 hours.There was no injury of the patient reported.We decided to report the issue as inability to position the patient as required leading to a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Event Description

On 22nd november, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113312b1 - alphamaxx sfc-pads, eu-side rails.During surgery on the anesthetized patient, the staff tried to operate the table with 2 different handsets and override panel.The table was not working.The override panel did not work at first and started to work on the second attempt.The surgery was continued and was finished with a delay of around 2 hours.There was no injury of the patient reported, however, we decided to report the issue as the inability to position the patient as required leading to a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Manufacturer Narrative

Getinge became aware of an issue with 113312b1 - alphamaxx sfc-pads, eu-side rails.During surgery on the anesthetized patient, the staff tried to operate the table with 2 different handsets and override panel.The table was not working.The override panel did not work at first and started to work on the second attempt.The surgery was continued and was finished with a delay of around 2 hours.There was no injury of the patient reported, however, we decided to report the issue as the inability to position the patient as required leading to a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.The affected getinge device has been evaluated by the company¿s service technician.All operating table¿s functions, handset and override panel were tested and worked up to the specification.The service technician checked the device with optiserp software and no malfunction within the operating table could be found.The device was returned to the usage and no exact root cause could have been established.With the investigation performed it was concluded that upon the event occurrence, the device was being used for patient¿s treatment, thus was also directly involved with the reported incident.As no actual malfunctions were found it was considered that getinge device was up to the specification.There were no similar complaints found related to this issue investigated here, therefore, it appear 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.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 22nd november, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113312b1 - alphamaxx sfc-pads, eu-side rails.As it was stated, the table stopped working during the surgery on the anesthetized patient.According to information provided by the customer, the staff tried to operate the table with 2 different handsets and override panel.It was reported that the override panel did not work at first, however, started to work on the second attempt.The surgery was continued and was finished with a delay of around 2 hours.There was no injury of the patient reported.We decided to report the issue as inability to position the patient as required leading to 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 22nd november, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113312b1 - alphamaxx sfc-pads, eu-side rails.During surgery on the anesthetized patient, the staff tried to operate the table with 2 different handsets and override panel.The table was not working.The override panel did not work at first and started to work on the second attempt.The surgery was continued and was finished with a delay of around 2 hours.There was no injury of the patient reported, however, we decided to report the issue as the inability to position the patient as required leading to a delay of surgery, resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

• Brand Name: ALPHAMAXX SFC-PADS, EU-SIDE RAILS
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon ; GM
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon ; GM
• MDR Report Key: 15867639
• MDR Text Key: 304331805
• Report Number: 8010652-2022-00042
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 113312B1
• Device Catalogue Number: 113312B1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 190 KG