MAUDE Adverse Event Report: MAQUET GMBH BASIC TABLE TOP; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	118010A0
Medical Device Problem Codes	Failure to Sense (1559); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1b event site name: kh barmherzige schwestern ried h3 other text : device not returned to manufacturer.
Event or Problem Description
On 15th december 2023 getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration.As it was stated, error 112 (the left and right segments have an inadmissible position difference) on segment 10 was displayed during a treatment on the anesthetized patient.The error resolved by itself, however, the issue led to a delay of approximately 2 minutes.According to the initial evaluation, no errors were found during the inspection.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration used with 118001a0 magnus table column for built-in plate.As it was stated, error 112 (the left and right segments have an inadimissible position difference) on segment 10 was displayed during a treatment on the anesthetized patient.The error resolved by itself, however, the issue led to a delay of approximately 2 minutes.According to the evaluation, no errors were found during the inspection.Following the table top readjustment no further issues occurred.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.It was established that the device met the manufacturer's specification as no malfunction was found.The device was being used for patient treatment when the malfunction occurred.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 full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.The correction of b5 describe event or problem, d1 brand name, d4 catalog #, d4 serial #, d4 unique identifier (udi) #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code ¿ explain, h4 device manufacture date and h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 15th december 2023 getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration.As it was stated, error 112 (the left and right segments have an inadimissible position difference) on segment 10 was displayed during a treatment on the anesthetized patient.The error resolved by itself, however, the issue led to a delay of approximately 2 minutes.According to the initial evaluation, no errors were found during the inspection.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration used with 118001a0 magnus table column for built-in plate.As it was stated, error 112 (the left and right segments have an inadimissible position difference) on segment 10 was displayed during a treatment on the anesthetized patient.The error resolved by itself, however, the issue led to a delay of approximately 2 minutes.According to the evaluation, no errors were found during the inspection.Following the table top readjustment no further issues occurred.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.Previous d1 brand name: basis table top,individual configuration corrected d1 brand name: electrical /electronic property problem|device sensing problem|failure to sense|1559.Previous d4 catalog #: 118010a0.Corrected d4 catalog #: n/a.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).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 h4 device manufacture date: 12/01/2012.Corrected h4 device manufacture date: 10/29/2012.Previous h6 medical device ¿ problem code: mechanical problem|mechanics altered|failure to align|2522.Corrected h6 medical device ¿ problem code: electrical /electronic property.Problem|device sensing problem|failure to sense|1559.
Event or Problem Description
Getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration used with 118001a0 magnus table column for built-in plate.As it was stated, error 112 (the left and right segments have an inadimissible position difference) on segment 10 was displayed during a treatment on the anesthetized patient.The error resolved by itself, however, the issue led to a delay of approximately 2 minutes.According to the evaluation, no errors were found during the inspection.Following the table top readjustment no further issues occurred.The incident was initially assessed as reportable due to a delay in surgery resulting in prolonged anesthesia time.Recently, the incident has been reevaluated as according to the medical expert's assessment, the procedural delay did not have any major clinical relevance in this situation.The scenario described in the record is considered as non-reportable.

• Brand Name: BASIC TABLE TOP
• 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: 18408185
• Report Number: 8010652-2023-00158
• Device Sequence Number: 15634292
• Product Code: FQO
• UDI-Device Identifier: 04046768031593
• UDI-Public: (01)04046768031593
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 12/28/2023

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: 118010A0
• Device Catalogue Number: 118010A0
• 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: 12/15/2023
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 118001A0 MAGNUS TABLE COLUMN FOR BUILT-IN PLATE
• Patient Sex: Unknown