MAUDE Adverse Event Report: HOLGER ULLRICH MEERA; TABLE, OPERATING-ROOM, AC-POWERED

Model Number MEERA

Device Problem Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.The full event site name is: (b)(6).

Event Description

We have received the user report "facility medwatch (b)(4)" from the fda.In this report an issue with one of our tables and head rests was described.The affected table is a mobile operating table of the "meera" model line.To this operating table several different models of head rests can be attached.We have requested further information concerning the affected products and the course of events from the customer, but not received them yet.The following was reported to us (direct quote from the medwatch): "after turning the meera bed used for neuro surgery 180 degrees for the purpose of the surgery, the head of the bed became completely detached and fell to the floor.The patients head was resting on the head portion of the bed and as a result, fell with it and the neck hyper extended.Patient was woken up enough to do a minimal neuro exam to ensure she could follow commands and move all four extremities.Patient was placed in a c-collar and more intense neuro exam was completed at the end of surgery.The patient could have broken her neck, or worse become paralyzed.The bed is either broken or was not attached properly by whoever set up the room." no injury of the patient was reported to us.

Manufacturer Narrative

A getinge-maquet service technician has visited the clinic and investigated the affected table and also other tables in hospital.The described malfunction could not be reproduced.No defect or malfunction was found on the table.Further information concerning this incident was requested from the clinic, but not provided.A use error cannot be excluded.The user is warned as follows in the instructions for use (ifu) concerning crushing and shearing hazards: warning! risk of injury! products / accessories not attached properly may loosen and cause injuries.Ensure that products / accessories are mounted correctly and that the securing elements (handle screws, catches, levers, etc.) are closed and firmly tightened, also ensure that moving parts are correctly secured.The correction of b5 describe event or problem field deems required.Previous b5 describe event or problem: we have received the user report "facility medwatch: (b)(4)" from the fda.In this report an issue with one of our tables and head rests was described.The affected table is a mobile operating table of the "meera" model line.To this operating table several different models of head rests can be attached.We have requested further information concerning the affected products and the course of events from the customer, but not received them yet.The following was reported to us (direct quote from the medwatch): "after turning the meera bed used for neuro surgery 180 degrees for the purpose of the surgery, the head of the bed became completely detached and fell to the floor.The patients head was resting on the head portion of the bed and as a result, fell with it and the neck hyper extended.Patient was woken up enough to do a minimal neuro exam to ensure she could follow commands and move all four extremities.Patient was placed in a c-collar and more intense neuro exam was completed at the end of surgery.The patient could have broken her neck, or worse become paralyzed.The bed is either broken or was not attached properly by whoever set up the room." no injury of the patient was reported to us.Corrected b5 describe event or problem: we have received the user report "facility medwatch (b)(4)" from the fda.In this report an issue with one of our tables and head rests was described.The affected table is a mobile operating table of the "meera" model line.To this operating table several different models of head rests can be attached.We had requested further information concerning the affected products and the course of events from the customer, but did not received them.The following was reported to us (direct quote from the medwatch): "after turning the meera bed used for neuro surgery 180 degrees for the purpose of the surgery, the head of the bed became completely detached and fell to the floor.The patients head was resting on the head portion of the bed and as a result, fell with it and the neck hyper extended.Patient was woken up enough to do a minimal neuro exam to ensure she could follow commands and move all four extremities.Patient was placed in a c-collar and more intense neuro exam was completed at the end of surgery.The patient could have broken her neck, or worse become paralyzed.The bed is either broken or was not attached properly by whoever set up the room." no injury of the patient was reported to us.

Event Description

We have received the user report "facility medwatch: (b)(4)" from the fda.In this report an issue with one of our tables and head rests was described.The affected table is a mobile operationg table of the "meera" model line.To this operationg table several different models of head rests can be attached.We had requested further information concerning the affected products and the course of events from the customer, but did not received them.The following was reported to us (direct quote from the medwatch): "after turning the meera bed used for neuro surgery 180 degrees for the purpose of the surgery, the head of the bed became completely detached and fell to the floor.The patients head was resting on the head portion of the bed and as a result, fell with it and the neck hyper extended.Patient was woken up enough to do a minimal neuro exam to ensure she could follow commands and move all four extremities.Patient was placed in a c-collar and more intense neuro exam was completed at the end of surgery.The patient could have broken her neck, or worse become paralyzed.The bed is either broken or was not attached properly by whoever set up the room." no injury of the patient was reported to us.

• Brand Name: MEERA
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 12506052
• MDR Text Key: 272485851
• Report Number: 8010652-2021-00027
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEERA
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Female