MAUDE Adverse Event Report: MAQUET GMBH TRANSPORTER CAN BE INCLINED, WASHABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 116061A0

Device Problem Break (1069)

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

Event Date 03/05/2021

Event Type  malfunction  

Event Description

On 5th march 2021 getinge became aware of an issue with one of our transporters - 116061a0 - transporter can be inclined, washable.The following was reported to us.The transporter is equipped with four castors.While a patient was transported in the or environment, a castor broke off.The treatment of the patient was continued on another or table.The incident resulted in a delay of 20 minutes.No injury was reported to us.Since the same malfunction resulted in a previous reportable complaint we decided to report the issue to the competent authorities.

Manufacturer Narrative

On 5th march 2021 getinge became aware of an issue with one of our transporters - 116061a0 - transporter can be inclined, washable.The following was reported to us.The transporter is equipped with four castors.While a patient was transported in the or environment, a castor broke off.The treatment of the patient was continued on another or table.The incident resulted in a delay of 20 minutes.No injury was reported to us.Since the same malfunction resulted in a previous reportable complaint we decided to report the issue to the competent authorities.According to the information obtained from the service unit, the device has been repaired by the conversion of defective castor to a newer version.The castors have been changed as part of a product improvement.Since the end of 2017, more stable castors have been used in production.It was established that when the event occurred, 116061a0 - transporter can be inclined, washable did not meet its specification.The device was 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 complaints related to the similar issue.Comparing the number of complained devices to the number of units placed on the market up to the march of 2021 (1568) we can conclude the failure ratio is 0,19% for the investigated issue.The defect described by the customer was found on a transporter 116061a0.We assume that the castor was pre-damaged due to a high or repeated force.This force might be caused e.G.By driving over obstacles or a hindrances.The pre-damaged castor broke off completely in the way described by the customer.In the instructions for use (ifu) the user is advised to remove potential hindrances when moving the transporter and to avoid collisions.Based on the available information we assume damages by user to be the root cause for this issue.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 (2021) 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 CAN BE INCLINED, WASHABLE
• 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: 15232444
• MDR Text Key: 303171220
• Report Number: 8010652-2022-00019
• 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
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 116061A0
• Device Catalogue Number: 116061A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1