MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 5000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number E5X2FC103BCASB

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The analysis of all gathered information is ongoing.The results of the analysis will be provided upon conclusions of the investigation.

Event Description

It was reported by the customer that the enterprise 5000x bed was damaged.No injury was reported.The service engineer inspected the bed and found that the backrest hinge broke in half, the frame was bent and the backrest gas spring was damaged.As a consequence of these failures, the backrest lowered and leaned on the head panel preventing it from lowering to the flat position.It was decided to replace the bed with the new one.According to the information provided by the facility staff, the damages occurred when the patient was raising the backrest without noticing that the backrest was blocked by an obstacle.

Manufacturer Narrative

It was reported by the customer that the enterprise 5000x bed was damaged.No injury was reported.The service engineer inspected the bed and found that the backrest hinge broke in half, the frame was bent and the backrest gas spring was damaged.As a consequence of these failures, the backrest lowered and was blocked on the bed¿s head panel, which prevented the backrest section from lowering to the flat position.It was decided to replace the bed with the new one.According to the information provided by the facility staff, the damages occurred when the patient was raising the backrest without noticing that the backrest was blocked by an obstacle.The instruction for use dedicated to enterprise 5000x bed (746.577) warns: ¿when the bed is operated, make sure that obstacles such as bedside furniture do not restrict its movement.¿ to sum up, there was a patient on the bed when the hinge broke and the backrest lowered leaning back on the head panel.The enterprise 5000x bed did not meet the specification during the event.The complaint was decided to be reportable due to the backrest hinge breakage during use with the patient that resulted in the partial lowering of the backrest section.

• Brand Name: ENTERPRISE 5000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 11647263
• MDR Text Key: 251672901
• Report Number: 3007420694-2021-00050
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982747707
• UDI-Public: (01)05055982747707(11)180604
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: E5X2FC103BCASB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other