MAUDE Adverse Event Report: MAQUET GMBH UNIVERSAL REMOTE DEVICE; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number	100925A0
Medical Device Problem Codes	Communication or Transmission Problem (2896); Positioning Problem (3009); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 2nd october 2023 getinge became aware of an issue with one of our accessories - 100925a0 universal remote control.As it was stated, the ir code on the universal remote control was changed during a knee prostesis operation on the anesthetized patient.According to the customer's allegation, the column could no longer be controlled due to the issue and the table top could not be adjusted.The issue led to a delay of approximately 3 minutes as the staff tried to organize a replacement remote control.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
Additional information will be provided following the conclusion of the investigation.(b)(6).H3 other text: device not returned to manufacturer.
Additional Manufacturer Narrative
The correction of h11 additional manufacturer narrative fields deems required.This is based on the internal evaluation and additional information that has been received.Previous h11 additional manufacturer narrative: getinge became aware of an issue with one of our accessories - 100925a0 universal remote control.As it was stated, the ir code on the universal remote control was changed during a knee prostesis operation on the anesthetized patient.According to the customer's allegation, the column could no longer be controlled due to the issue and the tabletop could not be adjusted.The issue led to a delay of approximately 3 minutes as the staff tried to organize a replacement remote control.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 failed to meet the manufacturer's specification.The device was being used for patient treatment when the malfunction occurred.The manufacturer has initiated the capa 2024-001 and ecr 24w181.The decision was made to perform fsca that is in the planning phase.Corrected h11 additional manufacturer narrative: getinge became aware of an issue with one of our accessories - 100925a0 universal remote control.As it was stated, the ir code on the universal remote control was changed during a knee prostesis operation on the anesthetized patient.According to the customer's allegation, the column could no longer be controlled due to the issue and the tabletop could not be adjusted.The issue led to a delay of approximately 3 minutes as the staff tried to organize a replacement remote control.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 failed to meet the manufacturer's specification.The device was being used for patient treatment when the malfunction occurred.The manufacturer has initiated the capa 2024-001, fsca 2024-001 and ecr 24w181.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our accessories - 100925a0 universal remote control.As it was stated, the ir code on the universal remote control was changed during a knee prostesis operation on the anesthetized patient.According to the customer's allegation, the column could no longer be controlled due to the issue and the table top could not be adjusted.The issue led to a delay of approximately 3 minutes as the staff tried to organize a replacement remote control.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 failed to meet the manufacturer's specification.The device was being used for patient treatment when the malfunction occurred.The manufacturer has initiated the capa 2024-001 and ecr 24w181.The decision was made to perform fsca that is in the planning phase.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 2nd october 2023 getinge became aware of an issue with one of our accessories - 100925a0 universal remote control.As it was stated, the ir code on the universal remote control was changed during a knee prostesis operation on the anesthetized patient.According to the customer's allegation, the column could no longer be controlled due to the issue and the table top could not be adjusted.The issue led to a delay of approximately 3 minutes as the staff tried to organize a replacement remote control.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: on 2nd october 2023 getinge became aware of an issue with one of our accessories - 100925a0 universal remote control.As it was stated, the ir code on the universal remote control was changed during a knee prostesis operation on the anesthetized patient.According to the customer's allegation, the column could no longer be controlled due to the issue and the table top could not be adjusted.The issue led to a delay of approximately 3 minutes as the staff tried to organize a replacement remote control.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: universal remote control.Corrected d1 brand name: universal remote device.Previous d4 catalog #: 100925a0.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 h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem||3009.Communication or transmission problem|||2896.Corrected h6 medical device ¿ problem code: communication or transmission problem|||2896.Electrical /electronic property problem|unexpected shutdown||a0719.Previous h6 component codes: electrical and magnetic|transmitter||3141.Corrected h6 component codes: mechanical|controller||765.Electrical and magnetic|computer software||4707.
Event or Problem Description
On 2nd october 2023 getinge became aware of an issue with one of our accessories - 100925a0 universal remote control.As it was stated, the ir code on the universal remote control was changed during a knee prostesis operation on the anesthetized patient.According to the customer's allegation, the column could no longer be controlled due to the issue and the tabletop could not be adjusted.The issue led to a delay of approximately 3 minutes as the staff tried to organize a replacement remote control.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: UNIVERSAL REMOTE DEVICE
• Common Device Name: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, 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: 17919485
• Report Number: 8010652-2023-00102
• Device Sequence Number: 19535712
• Product Code: JEA
• UDI-Device Identifier: 04046768134294
• UDI-Public: (01)04046768134294(11)220913
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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: 100925A0
• Device Catalogue Number: 100925A0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/11/2024; 10/24/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/24/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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: 116001A0 - OTESUS OR TABLE COLUMN.
• Patient Sex: Unknown