MAUDE Adverse Event Report: MAQUET GMBH MEERA ST EU WITHOUT AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 710001B0

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our mobile tables ¿ 710001b0 - meera st eu without auto drive.As it was stated, the mains supply cable and connection became overrheated after the table was connected to the 220v outlet.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the overheating of the mains cable and connection, was to reoccur.

Manufacturer Narrative

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

Event Description

On 23rd january 2023, getinge became aware of an issue with one of our mobile tables ¿ 710001b0 - meera st eu without auto drive.As it was stated and confirmed with the photographic evidence, the mains supply cable and connection became overheated after the table was connected to the 220v outlet.It was confirmed that only smoke appeared due to the issue.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the overheating of the mains cable and connection, was to reoccur.

Manufacturer Narrative

Getinge became aware of an issue with one of our mobile tables ¿ 710001b0 - meera st eu without auto drive.As it was stated, the mains supply cable and connection became overheated after the table was connected to the 220v outlet.It was confirmed that only smoke appeared due to the issue.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the overheating of the mains cable and connection, was to reoccur.The affected getinge device has been evaluated by the getinge technician who confirmed that the assembly main connection and the mains supply cable were melted.According to the technician, after connecting the table to the power supply, the hospital employee heard a loud noise and after that, the power cord melted.The technician replaced the affected assembly main connection (part number 37208271) and the mains supply cable (part number 31153423).The technician provided the photographic evidence of the affected parts.The pictures were forwarded to the subject matter expert (sme) at the manufacturing site for further analysis.The sme assumed that it is possible that the issue could be related to the general conditions of the electric supply and the state the installations are in.The technician performed tests to ensure that the correct electric current was reaching the equipment.No information about the abnormalities of the electric supply was provided.Moreover, the technician did not find any signs of wear and tear or damage by the user on the affected power cord.The service technician also confirmed that the user disconnected the mains supply cable of the table and the table¿s power cable remained connected to the wall electrical network.The meera mobile operating table is designed according to internationally valid iec 60601-1 standard which is the equivalent of din vde 0750, part 1.Iec 601-1 standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment.It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel.The underlying philosophy of the iec 60601-1 harmonized standards is that equipment must be safe in normal condition (nc) and single fault condition (sfc).Manufacturing the device according to the iec 60601-1 standard means that the device meets all necessary requirements and may be registered as a medical device in different countries.In the user manual the user is informed that to disconnect the plug at the main socket and then detach the mains cable from the operating table (ifu 7100.01 en 05, page 67).Despite the fact that the user did not follow the user manual, it cannot be confirmed that the user contributed to the reported issue as the mains supply was melted before the cable was disconnected.With the investigation performed it was concluded that upon the event occurrence, the device was not being used for the patient¿s treatment, but was directly involved with the reported incident.As the assembly main connection and the mains supply cable were melted, it was considered that the getinge device was not up to the specification.The root cause for this issue remained impossible to define.There were no similar customer product complaints related to same scenario as investigated here, therefore the issue investigated herein is a single and 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 field deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 23rd january 2023 getinge became aware of an issue with one of our mobile tables ¿ 710001b0 - meera st eu without auto drive.As it was stated, the mains supply cable and connection became overrheated after the table was connected to the 220v outlet.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the overheating of the mains cable and connection, was to reoccur.Corrected b5 describe event or problem: on 23rd january 2023, getinge became aware of an issue with one of our mobile tables ¿ 710001b0 - meera st eu without auto drive.As it was stated and confirmed with the photographic evidence, the mains supply cable and connection became overheated after the table was connected to the 220v outlet.It was confirmed that only smoke appeared due to the issue.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the overheating of the mains cable and connection, was to reoccur.

• Brand Name: MEERA ST EU WITHOUT AUTO DRIVE
• 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: 16325298
• MDR Text Key: 309074233
• Report Number: 8010652-2023-00009
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 710001B0
• Device Catalogue Number: 710001B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1