MAUDE Adverse Event Report: MAQUET GMBH BETASTAR MOBILE OPERATING-TABLE, EU; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113112B0

Device Problem Overheating of Device (1437)

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

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 16th august, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113112b0 - betastar mobile operating-table, eu.As it was stated, during cleaning of the mobile table, the damaged cable burned due to overheating.There was no injury reported due to the issue.However; serious injury in case of recurrence cannot be excluded.

Manufacturer Narrative

Getinge became aware of an issue with 113112b0 - betastar mobile operating-table.It was stated that during cleaning of the mobile table, the damaged cable became overheated.There was no injury reported due to the issue, however, serious injury in case of recurrence cannot be excluded.Based on the information provided by the getinge technician, the defective power supply cable and internal connector to transformer were replaced and the device is now working properly.It was established that when the event occurred, the mobile table did not meet its specification and it was directly involved with the reported incident.The provided information indicates that upon the event occurrence, the device was not used for patient treatment.The reported issue regarding the overheating of the damaged cable during the cleaning of the betastar mobile table is a single and isolated case per our complaint handling database.The getinge technician performed the assessment of the defective cable.According to the information provided by the technician, the damage, caused by poor contact due to wear and tear on the power cable connector, has been concentrated in the wiring and has not affected equipment mechanisms or other external elements.In the instruction for use the user is informed that to ensure correct operation, it is necessary to have visual and functional inspections performed by a trained person prior to each use.The user is informed that the electrical cables should be checked before each use and if any defects were detected, the user should not continue to use the product and inform the service personnel.The user continued to use the worn cable, therefore, the root cause for this issue is user error.If the user had followed the instruction for use and reported the faulty cable to the service personnel, the reported issue could have been avoided.We believe the related devices are performing correctly in the market.We also believe that if the instruction for use would been followed, the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any action at this time.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 16th august, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113112b0 - betastar mobile operating-table, eu.As it was stated, during cleaning of the mobile table, the damaged cable burned due to overheating.There was no injury reported due to the issue, however, serious injury in case of recurrence cannot be excluded.Corrected b5 describe event or problem: on 16th august, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113112b0 - betastar mobile operating-table, eu.As it was stated, during cleaning of the mobile table, the damaged cable became overheated.There was no injury reported due to the issue, however, serious injury in case of recurrence cannot be excluded.Based on the information provided by the getinge technician, the defective power supply cable and internal connector to transformer were replaced and the device is now working properly.H3 other text : device not returned to manufacturer.

Event Description

On 16th august, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113112b0 - betastar mobile operating-table, eu.As it was stated, during cleaning of the mobile table, the damaged cable became overheated.There was no injury reported due to the issue, however, serious injury in case of recurrence cannot be excluded.

• Brand Name: BETASTAR MOBILE OPERATING-TABLE, 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: 15281650
• MDR Text Key: 303349427
• Report Number: 8010652-2022-00025
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 113112B0
• Device Catalogue Number: 113112B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1