MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O ENTERPRISE 8000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 8X23GD113BAAAA

Device Problem Collapse (1099)

Patient Problem Discomfort (2330)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Following the information provided the patient was undergoing spine surgery, once completed he was transferred from the operating table to the bed.Once in bed the backrest section of the bed was tried to be raised without success.The bed's area was checked to ensure nothing was getting stuck under backrest but it still wouldn't move.It was decided that the patient will be transferred on the bed in current position.Two nurses started pushing the bed out of the theater when the bed collapsed and the backrest section of the bed dropped to its lowest point.As a result the patient felt discomfort.The bed was returned to manufacturer for further inspection.

Manufacturer Narrative

This report is being filed under exemption e2012070 by arjohuntleigh polska sp.Z o.O.(registration#(b)(4) on behalf of the importer arjohuntleigh, inc.(ahus) (registration#(b)(4) ).On 2018-jul-31 arjo became aware of a complaint involving enterprise 8000x bed.Following the information reported the patient was having spine surgery, while completed he was transferred from the operating table to the bed.Once the patient was lying on the bed the anesthesiologist tried to elevate the backrest section of the bed to sit the patient up, however without success.The bed's area was checked to ensure nothing was getting stuck under bed's backrest.Although there was no obstruction it was impossible to elevate the backrest.It was then decided that the patient would be transferred in the position he was.The nurses started pushing the bed out of the theater when the bed collapsed and the backrest dropped to its lowest point.There was no injury nor other medical consequences reported, only the patient was startled.Immediately after malfunction occurrence the facility staff transferred the patient to a new bed.The bed in question was returned from market for further inspection.The visual inspection revealed that although the c-clips securing the radius arms were present both radius arms detached from sub-frame.The middle section of the frame was bent.Additionally frame's hinge and gas spring on backrest side were broken.In order to verify the functionality of radius arms, they were re-attached to the sub-frame with use of new c-clips.The control panel buttons responsible for lowering and raising the bed were activated.Despite previous damages, high - low functions of the bed were working properly.It was impossible to recreate reported malfunction without any interference.The radius arms detachment was possible only by putting an obstacle between base frame and radius arms.While moving the bed to the lowest position one side of radius arm (where an obstacle was located) twisted and fell off frame's pin.Due to poor condition of the backrest section of the bed (frame's hinge broken, not working gas spring) it was impossible to load the bed and check backrest functionality.Additionally a lifting mechanisms dimensions were checked.The measurements made confirmed that that both radius arms were up to manufacturer's specification, there was no discrepancy with documentation found.Additionally affected backrest hinge was sent for x-ray to the external laboratory in order to check the compatibility of part material.The results provided confirm that the quality of tested casting is adequate.There is no presence of cold fills, shrinkages or foreign materials.According to research report, a chemical composition is in accordance with the manufacturer's specification.The enterprise 8000x bed (serial number: (b)(4) model number: 8x23gd113baaaa) manufactured on may 24th, 2018 was checked before being distributed to the customer and verified to meet the required manufacturer's specification.The device history record has been reviewed and no anomaly was found.Summarizing, the reported malfunction could have been recreated only when the radius arms movement was restricted by an obstacle.While the bed was operated with appropriate care there was no possibility of radius arms detachment.Additionally it needs to be emphasized that the middle section of the bed was bent, it could have been caused by an obstacle restricting bed's movement.It can be assumed that broken hinge in backrest section was the effect of bed collapse.Although there were no injuries reported, the complaint was decided to be reportable due to the allegation of the radius arm detachment.At the time the malfunction occurred there was a patient lying on the bed.The radius arm detached from bed's frame and from that perspective, the enterprise 8000x bed did not meet its manufacturer's specification.

• Brand Name: ENTERPRISE 8000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, ; PL
• MDR Report Key: 7826353
• MDR Text Key: 118557744
• Report Number: 3007420694-2018-00174
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8X23GD113BAAAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2018
• Distributor Facility Aware Date: 07/31/2018
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2018
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 74