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

Model Number	100925A0
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1a initial reporter: (b)(6).E1b event site name: (b)(6).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 accessories - 100925a0 - universal remote control.According to the customer allegation, the ir-code of remote control changed itself during the operation and the control could not be used.The malfunction resulted in approximately 30-minute delay in procedure until a replacement remote control was brought.In the meantime, the table was operated with the override panel.The surgery was completed as planned.The patient was under anesthesia and on a heart-lung machine when the issue occurred.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 accessories - 100925a0 - universal remote control used with 116001a0 otesus or table column, stationary.According to the customer allegation, the ir-code of remote control changed itself during the operation and the control could not be used.The malfunction resulted in approximately a 30-minute delay in procedure until a replacement remote control was brought.In the meantime, the table was operated with the override panel.The surgery was completed as planned.The patient was under anesthesia and on a heart-lung machine when the issue 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 failed to meet the manufacturer's specification.The device was being used for patient treatment when the malfunction occurred.The manufacturer initiated capa 2024-001 and fsca 2024-001.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 and h6 component codes fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 30th november 2023 getinge became aware of an issue with one of our accessories - 100925a0 - universal remote control.According to the customer allegation, the ir-code of remote control changed itself during the operation and the control could not be used.The malfunction resulted in approximately 30-minute delay in procedure until a replacement remote control was brought.In the meantime, the table was operated with the override panel.The surgery was completed as planned.The patient was under anesthesia and on a heart-lung machine when the issue occurred.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 30th november 2023, getinge became aware of an issue with one of our accessories - 100925a0 - universal remote control used with 116001a0 otesus or table column, stationary.According to the customer allegation, the ir-code of remote control changed itself during the operation and the control could not be used.The malfunction resulted in approximately a 30-minute delay in procedure until a replacement remote control was brought.In the meantime, the table was operated with the override panel.The surgery was completed as planned.The patient was under anesthesia and on a heart-lung machine when the issue 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: 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 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 30th november 2023, getinge became aware of an issue with one of our accessories - 100925a0 - universal remote control used with 116001a0 otesus or table column, stationary.According to the customer allegation, the ir-code of remote control changed itself during the operation and the control could not be used.The malfunction resulted in approximately a 30-minute delay in procedure until a replacement remote control was brought.In the meantime, the table was operated with the override panel.The surgery was completed as planned.The patient was under anesthesia and on a heart-lung machine when the issue 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: 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: 18334064
• Report Number: 8010652-2023-00141
• Device Sequence Number: 8451501
• Product Code: JEA
• UDI-Device Identifier: 04046768134294
• UDI-Public: (01)04046768134294(11)221025
• 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: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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