MAUDE Adverse Event Report: MAQUET GMBH TRANSPORTER, HEIGHT AND TREND.ADJUSTMENT; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 116062A0

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019, getinge became aware of an issue with one of our transporters - 116062a0 - transporter, height and trend.Adjustment.As it was stated, the transporter moved to the side during maneuvering.The user tried to hold the transporter and was injured.Further information concerning details of this incident (like further details concerning the injury and the affected serial number) were requested but not provided by the clinic.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.

Manufacturer Narrative

On (b)(6) 2019, getinge became aware of an issue with one of our transporters - 116062a0 - transporter, height and trend.Adjustment.As it was stated, the transporter moved to the side during maneuvering.The user tried to hold the transporter and was injured.Further information concerning details of this incident (like further details concerning the injury and the affected serial number) were requested but not provided by the clinic.We decided to report the issue as serious injury in case of event recurrence cannot be excluded.There were two 116062a0 transporters at customer¿s site.Unfortunately, the customer was not able to confirm which one was involved in the reported incident.Based on the available information, it was concluded that there was no malfunction with the device itself.Nevertheless, track roller conversion kit was created to resolve the investigated issue at sites that may experience the similar problems.Both transporters at the customer site were retrofitted.It was established that when the event occurred, 116062a0 transporter, height and trend.Adjustment did meet its specification.There is no information if the device was or was not being used for a patient¿s treatment upon the event occurrence.When the event occurred, the transporter was directly involved in the reported incident.There were two similar complaints related to this issue.Comparing the number of complained devices (3) to the number of units placed on the market (4150) we can conclude the failure ratio is 0,072% for the investigated issue.The transporter is equipped with a tracking wheel.This tracking wheel can be set on the floor (track guiding function enabled) or moved upwards (track guiding function disabled).The tracking wheel can be moved upwards or downwards by pushing a pedal.The user stated that the tracking wheel changed its position without this pedal being activated.The situation described by the user (tracking wheel moves upwards) may occur in case the transporter is moved over steps or on uneven floor.The customer stated that there was no uneven floor and no larger steps.This kind of issue may also occur in case the transporter is moved over small steps or around corners with increased speed.A video was provided on which it can be seen how the transporter is moved over a doorsill and the described issue occurred.The video was forwarded to the r&d department for assessment.It was confirmed that this kind of malfunction occurred due to the shown doorsill.In the instructions for use (ifu) the user is advised to remove potential hindrances when moving the transporter and to avoid collisions.Besides the user is told to guide the transporter with two persons to avoid collisions.The user is warned in the ifu about the risks related to pinching and shearing hazards for patient and personal.The intended purpose described in the ifu states that the transporter is to be used by trained staff within the or environment.The production records were checked for both transporters and no issues were found.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The event has been reported with a delay due to our retrospective examination of the record.At the time (2019) the complaint was reviewed and found not to be reportable in the us.Current day, we compared the registration list, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we have reported it now.Device not returned to manufacturer.

• Brand Name: TRANSPORTER, HEIGHT AND TREND.ADJUSTMENT
• 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: 15247968
• MDR Text Key: 305510743
• Report Number: 8010652-2022-00023
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 116062A0
• Device Catalogue Number: 116062A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other