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

Model Number 113322B5

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/20/2023

Event Type  malfunction  

Event Description

On 20th july 2023 getinge became aware of an incident with one of our mobile tables - 113322b5 - alphamaxx (460 mm longit.Shift), eu.As it was stated, table ran over someone¿s foot leading to an unspecified injury.It is presumed that the table might have been pushed into somebody's foot.When the table is raised onto its castors it is only 10 mm off the floor which makes it difficult to get a foot under the table.The circumstances of the incident or details of the sustained injury were not provided.We decided to report the issue based on the potential for serious injury if the situation, namely the table running over or being pressed on somebody's foot, was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.(b)(6).H3 other text : device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an incident with one of our mobile tables - 113322b5 - alphamaxx (460 mm longitudinal shift).As it was stated, the table hit a person¿s foot leading to an unspecified injury.It is presumed that the table might have been pushed onto the foot as when the table is raised onto its castors it becomes moved to only 10 mm off the floor, a gap which makes it difficult to get a foot under the table.The circumstances of the incident or details of the sustained injury were not provided.We decided to report the issue based on the potential for serious injury if the situation, namely the table hitting somebody's foot, was to reoccur.With the investigation performed it was concluded that upon the event occurrence, the device was not being used for the patient¿s treatment or diagnosis, however, was directly involved with the reported incident.A malfunction of the column covers and base was found.The covers were buckled and the base has been scuffed.These were assessed by the technician as not related to the event as they did not lead to it and were not caused by the table hitting the user.They were a result of previous user damage.It was considered that by the time of the event the getinge did not fail to meet its specification in a way that is relevant to the event and outcome.A review of the received customer product complaints revealed that there were no serious injuries to a user nor to a patient or operator when this particular issue occurred.The complaint investigated herein is a single and isolated case.After the repair the getinge device was released for usage.In the instructions for use (ga 1133.22 en 08, page 42), the user is warned about risk of injury.The user is advised to hold the or table firmly before extending the swivel castors in order to ensure it cannot roll away unintentionally.It may have been the case that the user utilized the operating table disregarding safety notes and suggestions from the user manual.In summary and as a result of the performed root cause evaluation, it was concluded that the most probable root cause of the reported issue, the operating table hitting someone¿s foot leading to an unspecified injury, was related to the user error.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 20th july 2023 getinge became aware of an incident with one of our mobile tables - 113322b5 - alphamaxx (460 mm longit.Shift), eu.As it was stated, table ran over someone¿s foot leading to an unspecified injury.It is presumed that the table might have been pushed into somebody's foot.When the table is raised onto its castors it is only 10 mm off the floor which makes it difficult to get a foot under the table.The circumstances of the incident or details of the sustained injury were not provided.We decided to report the issue based on the potential for serious injury if the situation, namely the table running over or being pressed on somebody's foot, was to reoccur.Corrected b5 describe event or problem: on 20th july 2023 getinge became aware of an incident with one of our mobile tables - 113322b5 - alphamaxx (460 mm longitudinal shift).As it was stated, the table hit a person¿s foot leading to an unspecified injury.It is presumed that the table might have been pushed onto the foot as when the table is raised onto its castors it becomes moved to only 10 mm off the floor, a gap which makes it difficult to get a foot under the table.The circumstances of the incident or details of the sustained injury were not provided.We decided to report the issue based on the potential for serious injury if the situation, namely the table hitting somebody's foot, was to reoccur.

Event Description

On 20th july 2023 getinge became aware of an incident with one of our mobile tables - 113322b5 - alphamaxx (460 mm longitudinal shift).As it was stated, the table hit a person¿s foot leading to an unspecified injury.It is presumed that the table might have been pushed onto the foot as when the table is raised onto its castors it becomes moved to only 10 mm off the floor, a gap which makes it difficult to get a foot under the table.The circumstances of the incident or details of the sustained injury were not provided.We decided to report the issue based on the potential for serious injury if the situation, namely the table hitting somebody's foot, was to reoccur.

• 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: 18009320
• MDR Text Key: 326560958
• Report Number: 8010652-2023-00115
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• 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: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other