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

Model Number	720001B2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site telephone and postal code: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b2 meera eu with auto drive.As it was stated, the patient fell off the operating table due to the hospital technician over tilting it.The surgery could be completed successfully.There was no injury for the patient reported, however, we decided to report the issue as patient falling off the operating table, could lead to serious injury in case of event reocurrence.
Event or Problem Description
On 19th september 2023, getinge became aware of an issue with one of our mobile tables ¿ 720001b2 meera eu with auto drive.As it was stated, the patient fell off the operating table due to the hospital technician over tilting it.The surgery could be completed successfully.There was no injury for the patient reported, however, we decided to report the issue as the patient falling off the operating table, could lead to serious injury in case of event reoccurrence.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our mobile tables ¿ 720001b2 meera eu with auto drive.As it was stated, the patient fell off the operating table due to the hospital technician over tilting it.The surgery could be completed successfully.There was no injury for the patient reported, however, we decided to report the issue as the patient falling off the operating table, could lead to serious injury in case of event reoccurrence.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.No malfunction was found.Therefore, it was considered that the getinge device meet its specifications.Comparing the number of devices involved in the adverse event to the amount of meera operating table placed on the market we can conclude the failure ratio is (b)(4) for the issue investigated herein.According to the getinge technician, the affected device was removed from service.Following the incident, the technician thoroughly evaluated the operating table and found no malfunctions or anomalies.The examination confirmed that the table was operational, all parts were intact, and there were no unwanted movements.Since no malfunctions or irregularities were detected, the technician suggested that the event was likely due to human error, what was confirmed by the hospital staff.In the instructions for use for the operating table (ifu 7200.01 rev.11, page 48), the customer is informed that if the patient is not secured, particularly when adjusting/moving, the patient and/or their extremities may slip in an uncontrolled manner.The patient should be secured using suitable aids (e.G.Straps) and remained under continuous observation.Additionally, users are warned (ifu 7200.01 rev.11, page 91) that the patient may be endangered as a result of incorrect use.The instructions for use for all accessories should be followed.In summary and as a result of the performed root cause evaluation, it can be concluded that the most possible root cause of the reported issue, was caused by user error and non-compliance with the user manual.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 b3 date of event, b5 describe event or problem, d1 brand name, d4 catalog #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain and h6 health effect ¿ clinical code fields deems required.This is based on the internal evaluation.Previous b3 date of event: 09/20/2023.Corrected b3 date of event: 09/18/2023.Previous b5 describe event or problem: on 20th september 2023 getinge became aware of an issue with one of our mobile tables ¿ 720001b2 meera eu with auto drive.As it was stated, the patient fell off the operating table due to the hospital technician over tilting it.The surgery could be completed successfully.There was no injury for the patient reported, however, we decided to report the issue as patient falling off the operating table, could lead to serious injury in case of event reocurrence.Corrected b5 describe event or problem: on 19th september 2023, getinge became aware of an issue with one of our mobile tables ¿ 720001b2 meera eu with auto drive.As it was stated, the patient fell off the operating table due to the hospital technician over tilting it.The surgery could be completed successfully.There was no injury for the patient reported, however, we decided to report the issue as the patient falling off the operating table, could lead to serious injury in case of event reoccurrence.Previous d1 brand name: meera eu with auto drive.Corrected d1 brand name: meera mobile operating table.Previous d4 catalog #: 720001b2.Corrected d4 catalog #: n/a.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Previous h6 health effect ¿ clinical code: injury|fall||1848.Corrected h6 health effect ¿ clinical code: others|no clinical signs, symptoms or conditions||4582.

• Brand Name: MEERA MOBILE OPERATING TABLE
• Common Device Name: 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: 17798131
• Report Number: 8010652-2023-00090
• Device Sequence Number: 12184109
• Product Code: FQO
• UDI-Device Identifier: 04046768124349
• UDI-Public: (01)04046768124349(11)230302
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 720001B2
• Device Catalogue Number: 720001B2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown