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

Model Number 113102B0

Device Problems Sparking (2595); Device Unsafe to Use in Environment (2918); Device Handling Problem (3265)

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

Event Date 07/27/2022

Event Type  malfunction  

Event Description

On 24th august, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113102b0 - betastar mobil operating table.As it was stated, during arthroscopy surgery water ingress appeared on the floor.According to the initially provided information, the staff disconnected power supply cable of the table from the wall power supply which generated an electric spark.There was no injury reported, however, we decided to report the issue in abundance of caution as serious injury in case of event recurrence cannot be excluded.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

Getinge became aware of an issue with 113102b0 - betastar mobile operating table as it was stated, during arthroscopy procedure water was present on the floor.The staff disconnected the power supply cable from the table.The table¿s power cable remained connected to the electrical network and the electric spark was allegedly generated.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely electrical spark occurring in wet conditions that could potentially led to electric shock, was to reoccur.The qualified representative met with the customer and investigated the issue.Confirmation of the defect has not been received.According to the information gathered the reported incident was caused by a user error who disconnected the power supply cable of the table but the table¿s power cable remained connected to the wall electrical network.In the user manual the user is informed that to disconnect the operating table from the supply, the power cord from the wall socket should be detached (ga113102gb03, page 12).Technical retraining for the user was performed to reinforce the correct use of the tables.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As no technical deficiency within the affected table could be confirmed, it was considered that the getinge device was up to specification.There were no similar complaints found related to this issue investigated here, therefore it appears to be isolated to this single occurrence when considering this particular device range, thus the investigated issue is considered an isolated case.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 and h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 24th august, 2022 getinge became aware of an issue with one of our mobile tables ¿ 113102b0 - betastar mobil operating table.As it was stated, during arthroscopy surgery water ingress appeared on the floor.According to the initially provided information, the staff disconnected power supply cable of the table from the wall power supply which generated an electric spark.There was no injury reported, however, we decided to report the issue in abundance of caution as serious injury in case of event recurrence cannot be excluded.Corrected b5 describe event or problem: on 24th august 2022 getinge became aware of an issue with one of our mobile tables ¿ 113102b0 - betastar mobile operating table.As it was stated, during arthroscopy procedure water was present on the floor.The staff disconnected the power supply cable from the table.The table¿s power cable remained connected to the electrical network and the electric spark was allegedly generated.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely electrical spark occurring in wet conditions that could potentially led to electric shock, was to reoccur.The complaint has been reported to getinge by the distributor.The customer was asked about more details in this case but did not provide any additional information.Previous h6 medical device ¿ problem code: electrical /electronic property problem|sparking||259.Environmental compatibility problem|device unsafe to use in environment||2918.Corrected h6 medical device ¿ problem code: electrical /electronic property problem|sparking||259.Use of device problem|device handling problem||3265.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our mobile tables ¿ 113102b0 - betastar mobile operating table.As it was stated, during arthroscopy procedure water was present on the floor.The staff disconnected the power supply cable from the table.The table¿s power cable remained connected to the electrical network and the electric spark was allegedly generated.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely electrical spark occurring in wet conditions that could potentially led to electric shock, was to reoccur.The complaint has been reported to getinge by the distributor.The customer was asked about more details in this case but did not provide any additional information.

• Brand Name: BETASTAR MOBIL OPERATING TABLE
• 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: 15318462
• MDR Text Key: 305373267
• Report Number: 8010652-2022-00026
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 113102B0
• Device Catalogue Number: 113102B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1