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

Model Number 114020AN

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problems Death (1802); Fall (1848)

Event Date 12/04/2019

Event Type  Death  

Manufacturer Narrative

Two getinge-maquet service technicians have investigated the affected table top.This investigation revealed that the table top has no defect and no malfunction.No trouble was found during this investigation.We were informed that the table top is in use for operations again.The affected table top is equipped with an adjustable back plate.This back plate can be elevated or lowered after two eccentric levers are opened.To open the eccentric levers, a push button has to be pressed.This has to be done for safety reasons.Only when the buttons are pressed, it is possible to open these levers.In the instructions for use (ifu) it is described how the back plate can be adjusted.It is stated that the back plate has to be supported with one hand when the eccentric levers are opened.The clinics biomedical engineer stated that during the surgery one of the levers for the release of the back plate was opened and the back plate moved down.The back plate is secured with two levers.It is not possible to determine afterwards whether the second lever was not or not properly closed or released intentionally or not intentionally.It is possible that the back plate was overloaded, e.G.By attaching accessories to it and the weight of this overloaded back plate could not be supported by the user.The affected table top was investigated by two getinge-maquet service technicians and the clinics biomed.No trouble was found.With the provided information no further investigation is possible.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.The event site name is (b)(4).

Event Description

It was reported that during an operation the back plate of the affected table turned down and as a result the patient fell of the table.Further it was reported that the patient died.Further details concerning this incident were requested from the clinic, but not provided.We asked the clinic among other things, whether and how the patient was secured, how exactly this incident happened, what kind of surgery or treatment was performed.We asked the clinic multiple times whether the patient died as a consequence of the fall.We have been informed by the clinic that no further information about the course of this event or the patients condition can be passed on.Manufacturer reference # (b)(4).

Manufacturer Narrative

The correction of b5 describe event or problem, d3 manufacturer and h10 addtl mfg narrative fields deems required.This is based on the internal evaluation and the additional information that has been received.Previous b5 describe event or problem: it was reported that during an operation the back plate of the affected table turned down and as a result the patient fell of the table.Further it was reported that the patient died.Further details concerning this incident were requested from the clinic, but not provided.We asked the clinic among other things, whether and how the patient was secured, how exactly this incident happened, what kind of surgery or treatment was performed.We asked the clinic multiple times whether the patient died as a consequence of the fall.We have been informed by the clinic that no further information about the course of this event or the patients condition can be passed on.Manufacturer reference#: (b)(4).Corrected b5 describe event or problem: on 5th december 2019, getinge became aware of an issue with 114020an - extensions table top.As it was stated, during an operation the back plate of the affected table turned down and as a result, the patient fell off the table.Further, it was reported that the patient died.More details about the incident, the type of surgery and information if the patient was secured with belts were requested from the clinic, but not provided.The customer did not provide information whether the patient died as a consequence of the fall.The customer informed that no further information about the course of this event or the patient¿s condition can be passed on.Previous d3 manufacturer: holger ullrich.Corrected d3 manufacturer: maquet gmbh.Previous h10 addtl mfg narrative: two getinge-maquet service technicians have investigated the affected table top.This investigation revealed that the table top has no defect and no malfunction.No trouble was found during this investigation.We were informed that the table top is in use for operations again.The affected table top is equipped with an adjustable back plate.This back plate can be elevated or lowered after two eccentric levers are opened.To open the eccentric levers, a push button has to be pressed.This has to be done for safety reasons.Only when the buttons are pressed, it is possible to open these levers.In the instructions for use (ifu) it is described how the back plate can be adjusted.It is stated that the back plate has to be supported with one hand when the eccentric levers are opened.The clinics biomedical engineer stated that during the surgery one of the levers for the release of the back plate was opened and the back plate moved down.The back plate is secured with two levers.It is not possible to determine afterwards whether the second lever was not or not properly closed or released intentionally or not intentionally.It is possible that the back plate was overloaded, e.G.By attaching accessories to it and the weight of this overloaded back plate could not be supported by the user.The affected table top was investigated by two getinge-maquet service technicians and the clinics biomed.No trouble was found.With the provided information no further investigation is possible.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.The event site name is (b)(6).Corrected h10 addtl mfg narrative: getinge became aware of an issue with 114020an - extensions table top.During an operation, the back plate of the affected table turned down and as a result, the patient fell off the table.Further, it was reported that the patient died.More details about the incident, the type of surgery and information if the patient was secured with belts were requested from the clinic, but not provided.The customer did not provide information whether the patient died as a consequence of the fall.The customer informed that no further information about the course of this event or the patient¿s condition can be passed on.The affected getinge device has been evaluated by the company¿s service technicians.This investigation revealed that the table top has no defect and no malfunction.No trouble was found during this investigation.The customer provided information that the table top is in use for operations again.The clinic¿s biomedical engineer stated that during the surgery one of the levers for the release of the back plate was opened and the back plate moved down.The back plate is secured with two levers.It is not possible to determine afterward whether the second lever was not properly closed or released intentionally or not intentionally.It is possible that the back plate was overloaded, e.G.By attaching accessories to it and the weight of this overloaded back plate could not be supported by the user.As no malfunction with the table top was found, probably user error contributed to the reported issue.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.As no actual malfunctions were found it was considered that the getinge device was up to specification.There was one similar complaint found related to this issue investigated here, so the failure ratio is (b)(4).Getinge initiated a field action fa 2021-011 (z-0239-2023) in november 2022 for the extension table top for operating table system 1140 for catalog numbers 114020f0 and 114020an due to the potential of the hazardous situation of swinging of the back plate if an extension bar will open the eccentric lever of the back plate.Field action was launched in order to inform the customers to perform pre-use checks of all table top functionalities (including and specifically the safety eccentric levers) and to perform/request regular preventive maintenance by a getinge authorized field service technician.Furthermore, if the last service is more than 12 months ago, an appointment to service the device is indispensable.

Event Description

On 5th december 2019, getinge became aware of an issue with 114020an - extensions table top.As it was stated, during an operation the back plate of the affected table turned down and as a result, the patient fell off the table.Further, it was reported that the patient died.More details about the incident, the type of surgery and information if the patient was secured with belts were requested from the clinic, but not provided.The customer did not provide information whether the patient died as a consequence of the fall.The customer informed that no further information about the course of this event or the patient¿s condition can be passed on.

• Brand Name: EXTENSIONS TABLE TOP
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: holger ullrich ; kehler strasse 31; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 9444055
• MDR Text Key: 170040898
• Report Number: 8010652-2019-00028
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 114020AN
• Device Catalogue Number: 114020AN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0239-2023
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Death
• Patient Weight: 117 KG