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

Model Number 116062A0

Device Problem Fracture (1260)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

On 12th october 2021, getinge became aware of an issue with a defective castor on one of our transporters - 116062a0 - transporter, height and trend.Adjustment.On 25th october 2021, we were informed that a patient was involved in this incident.The following was reported to us.The transporter has four castors.When transporting a patient to the operating room, one of the castors broke off.The patient was secured with belts and was transferred.The move took about 20 to 30 minutes.No patient injuries were reported to us.Since the same malfunction resulted in a previous report 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 replacement of the defective castor.It was established that when the event occurred, 116062a0 transporter, height and trend.Adjustment 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 three complaints related to the similar issue.Comparing the number of complained devices (4) to the number of units placed on the market up to the end of october 2021 (b)(4) for the investigated issue.The defect described by the customer was found on a transporter 116062a0.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 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.

Event Description

On 12th october 2021, getinge became aware of an issue with a defective castor on one of our transporters - 116062a0 - transporter, height and trend.Adjustment.On 25th october 2021, we were informed that a patient was involved in this incident.The following was reported to us.The transporter has four castors.When transporting a patient to the operating room, one of the castors broke off.The patient was secured with belts and was transferred.The move took about 20 to 30 minutes.No patient injuries were reported to us.Since the same malfunction resulted in a previous report we decided to report the issue to the competent authorities.

• 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: 15208436
• MDR Text Key: 305347006
• Report Number: 8010652-2022-00015
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 116062A0
• Device Catalogue Number: 116062A0
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1