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

Model Number 114020AN

Device Problems Fail-Safe Problem (2936); Unintended Movement (3026); Insufficient Information (3190); Device Handling Problem (3265)

Patient Problems Death (1802); Fall (1848); Head Injury (1879); Laceration(s) (1946)

Event Date 01/02/2020

Event Type  Death  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.As soon as the investigation is finished the report will be updated and a follow-up report will be provided.

Event Description

It was reported that a patient died.Further information concerning the course of the event and relation to the device was requested but not yet received.Manufacturer reference# (b)(4).

Manufacturer Narrative

A getinge-maquet service technician has investigated the affected table to.He has found that two push buttons were defective.These push buttons are part of a safety mechanism to avoid the accidental release of the eccentric levers.If both eccentric levers are released, the back plate is unlocked and can be moved.If these two push buttons are defective, the product is not meeting its specification and should not be used.In this case, the product was used despite this defect.The two eccentric levers were accidentally released when the extension bars were adjusted.The back plate fell downwards.In the instructions for use (ifu) the user is advised that once per year a maintenance should be performed on the table to ensure operational safety.This maintenance should be performed by an authorized service engineer.For this table the described maintenance was not performed by getinge-maquet.Lack of maintenance may have contributed to this event.

Event Description

The following was reported.The patient was positioned on the table top and the back plate was fixed.The back plate can be moved by releasing two excentric levers.In this case the levers were opened accidentally when two extension bars were rotated.The back plate was no longer locked and swung downwards.As a consequence the patient fell off the table.A doctor from the clinic stated that a cerebral and cervical ct scan was performed after the fall.The result of this scans was that only cutaneous lesions were present.The doctor stated, that he believed the patient did not die due to the fall.He stated, that in addition to his age (92 years) the patient had a high co-morbidity and died when they were finishing the intervention.Manufacturer reference# (b)(4).

Event Description

On 2nd january 2020, getinge became aware of an issue with 114020an - extensions table top.As it was stated, the (b)(6) patient was positioned on the table top and the back plate was fixed.The back plate can be moved by releasing two excentric levers.In this case, the levers were opened accidentally when two extension bars were rotated.The back plate was no longer locked and swung downwards.As a consequence, the patient fell off the table.The patient died.A doctor from the clinic stated that a cerebral and cervical ct scan was performed after the fall.The result of these scans was that only cutaneous lesions were present.The doctor stated, that he believed the patient did not die due to the fall.He stated, that in addition to his age the patient had a high co-morbidity and died when they were finishing the intervention.

Manufacturer Narrative

The correction of b5 describe event or problem and h10 addtl mfg narrative fields deems required.This is based on the internal evaluation and additional information that has been received.Previous b5 describe event or problem: the following was reported.The patient was positioned on the table top and the back plate was fixed.The back plate can be moved by releasing two excentric levers.In this case the levers were opened accidentally when two extension bars were rotated.The back plate was no longer locked and swung downwards.As a consequence the patient fell off the table.A doctor from the clinic stated that a cerebral and cervical ct scan was performed after the fall.The result of this scans was that only cutaneous lesions were present.The doctor stated, that he believed the patient did not die due to the fall.He stated, that in addition to his age ((b)(6)) the patient had a high co-morbidity and died when they were finishing the intervention.Manufacturer reference# (b)(4).Corrected b5 describe event or problem: on 2nd january 2020, getinge became aware of an issue with 114020an - extensions table top.As it was stated, the (b)(6) patient was positioned on the table top and the back plate was fixed.The back plate can be moved by releasing two excentric levers.In this case, the levers were opened accidentally when two extension bars were rotated.The back plate was no longer locked and swung downwards.As a consequence, the patient fell off the table.The patient died.A doctor from the clinic stated that a cerebral and cervical ct scan was performed after the fall.The result of these scans was that only cutaneous lesions were present.The doctor stated, that he believed the patient did not die due to the fall.He stated, that in addition to his age the patient had a high co-morbidity and died when they were finishing the intervention.Previous h10 addtl mfg narrative: a getinge-maquet service technician has investigated the affected table top.He has found that two push buttons were defective.These push buttons are part of a safety mechanism to avoid the accidental release of the eccentric levers.If both eccentric levers are released, the back plate is unlocked and can be moved.If these two push buttons are defective, the product is not meeting its specification and should not be used.In this case, the product was used despite this defect.The two eccentric levers were accidentally released when the extension bars were adjusted.The back plate fell downwards.In the instructions for use (ifu) the user is advised that once per year a maintenance should be performed on the table to ensure operational safety.This maintenance should be performed by an authorized service engineer.For this table the described maintenance was not performed by getinge-maquet.Lack of maintenance may have contributed to this event.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.Corrected h10 addtl mfg narrative: getinge became aware of an issue with 114020an - extensions table top.The (b)(6) patient fell off the table due to the back plate swinging downwards.A cerebral and cervical ct scan was performed after the fall and only cutaneous lesions were present.The patient died, but the doctor stated that he believed the patient did not die due to the fall and in addition to his age the patient had a high co-morbidity and died when they were finishing the intervention.The affected extension table top has been evaluated by the company¿s service technician.Two push buttons were found to be defective.After replacing the defective push buttons the device was released for usage.This particular device range has been discontinued in the production since 2008 and the end of service for the installed base took place in 2018.In the instructions for use the user is advised that once per year maintenance should be performed on the table to ensure operational safety.This maintenance should be performed by an authorized service engineer.For this table, the described maintenance was not performed by getinge.Lack of maintenance may have contributed to this event so the root cause for this issue is user error.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, thus was also directly involved with the reported incident.As the malfunction of push buttons was found, it was considered that the getinge device was not up to the 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 (b)(6) 2022 for the extension table top for operating table system 1140 for catalog numbers 114020f0 and 114020an due to the potential of 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.

• Brand Name: EXTENSION TABLE TOP
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: kehler strasse 31; rastatt
• MDR Report Key: 9574270
• MDR Text Key: 174473704
• Report Number: 3013876692-2020-00004
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 114020AN
• Device Catalogue Number: 114020AN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2022
• Distributor Facility Aware Date: 11/15/2022
• Device Age: 151 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2022
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: Z-0239-2023
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Outcome(s): Other; Death
• Patient Age: 92 YR
• Patient Sex: Prefer Not To Disclose