MAUDE Adverse Event Report: MAQUET GMBH ALPHAMAXX (460 MM LONGIT. SHIFT), EU; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113322B5

Device Problems Device Slipped (1584); Naturally Worn (2988); Device Handling Problem (3265)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

On 16th november, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113322b5 - alphamaxx (460 mm longit.Shift), eu.As it was stated, during positioning of the anesthetized patient, mattress did not adhere to the table top and moved causing the patient to slip down the table.The patient was transferred to another table which resulted in a delay of surgery.There was no injury reported, however, we decided to report the issue based on potential as unintended significant change in the patient¿s position and delay of surgery resulting in prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Initial reporter: (b)(6).

Event Description

On 16th november, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113322b5 - alphamaxx (460 mm longit.Shift), eu.As it was stated, during positioning of the anesthetized patient, mattress did not adhere to the table top and moved, causing the patient to slip down from the table.The patient did not fall down on the floor.By the time of the incident the patient was lying down on back and was not secured with straps.Following the incident, the patient was transferred to another table, which resulted in a delay of surgery.The surgery was carried on after the transfer to another table.There was no injury reported, however, we decided to report the issue based on potential as patient slipping from the table leading to a delay of surgery and prolonged anesthesia time, could lead to serious injury in case of event recurrence.

Manufacturer Narrative

Getinge became aware of an issue with one of our mobile tables ¿ 113322b5 - alphamaxx (460 mm longit.Shift), eu.As it was stated, during positioning of the anesthetized patient, mattress did not adhere to the table top and moved causing the patient to slip down the table.The patient did not fall down on the floor.By the time of the incident the patient was lying down on back and was not secured with straps.Following the incident, the patient was transferred to another table, which resulted in a delay of surgery.The surgery was carried on after the transfer to another table.There was no injury reported, however, we decided to report the issue based on potential as patient slipping from the table leading to a delay of surgery and prolonged anesthesia time, could lead to serious injury in case of event recurrence.It has been evaluated that velcro was defective.New velcro was delivered to the customer to be installed by themselves as this particular customer does not own a service agreement with getinge.In the instruction for use (ifu 1133.22 en 16, page 24) the user is warned that if the patient is not secured, particularly when adjusting/moving, the patient and/or their extremities may slip in an uncontrolled manner.To avoid the risk of slipping the patient off the table the patient should be always secured using suitable aids (e.G.Straps) and maintained under continuous observation.Additionally in the maintenance chapter the user is informed to ensure correct operation of the operating table, it is necessary to have visual and functional inspections performed by a trained person prior to each use.In the suggested visual and functional inspection (ifu 1133.22 en 16, page 108) user should check whether the padding no longer adheres.If this is true user should not use the padding any longer.According to the provided information, the customer has performed a pre-use check.However, as the padding adhering force failed shortly after the inspection it is assumed that the inspection was not performed sufficiently.As the user manipulated the table with patient on it and disregarded safety notes and suggestions from user manual the root cause for this issue is user error.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 velcro was found, it was considered that the getinge device was not up to the specification.In summary, this complaint is the first one registered for alphamaxx operating tables where the patient¿s anesthesia time was prolonged due to the fact that patient slipped down the table due to pad adherence issue.Comparing the number of complained devices (1) to the number of alphamaxx operating tables with aforementioned catalog numbers placed on the market we can conclude the failure ratio is 0,05% for the issue investigated herein and the investigated issue is single and 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 and additional information that has been received.Previous b5 describe event or problem: on 16th november, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113322b5 - alphamaxx (460 mm longit.Shift), eu.As it was stated, during positioning of the anesthetized patient, mattress did not adhere to the table top and moved causing the patient to slip down the table.The patient was transferred to another table which resulted in a delay of surgery.There was no injury reported, however, we decided to report the issue based on potential as unintended significant change in the patient¿s position and 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 16th november, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113322b5 - alphamaxx (460 mm longit.Shift), eu.As it was stated, during positioning of the anesthetized patient, mattress did not adhere to the table top and moved, causing the patient to slip down from the table.The patient did not fall down on the floor.By the time of the incident the patient was lying down on back and was not secured with straps.Following the incident, the patient was transferred to another table, which resulted in a delay of surgery.The surgery was carried on after the transfer to another table.There was no injury reported, however, we decided to report the issue based on potential as patient slipping from the table leading to a delay of surgery and prolonged anesthesia time, could lead to serious injury in case of event recurrence.

• Brand Name: ALPHAMAXX (460 MM LONGIT. SHIFT), EU
• 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: 15860598
• MDR Text Key: 305696280
• Report Number: 8010652-2022-00041
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 113322B5
• Device Catalogue Number: 113322B5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1