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

Model Number E5X2FC103BCASB

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  Injury  

Manufacturer Narrative

The process of gathering and analyzing information is ongoing.The results of the investigation will be provided upon conclusions of the investigation.

Event Description

Following information reported by the end user, the enterprise 5000x bed was damaged.There was no indication regarding patient involvement.No injury was reported.The device evaluation performed by arjo technician revealed that the bed frame and backrest were damaged and one of the upper arms and lower arm detached.

Manufacturer Narrative

Following information reported by the end-user, the enterprise 5000x bed was damaged.There was a patient on the bed.No injury was reported.The device evaluation performed by the arjo technician revealed that one of the upper arms and lower arm detached and the middle section of the bed and backrest frame were bent.It was decided to replace the bed with the new one.In arjo technician¿s opinion, observed damages may prove that the side panel was blocked by the obstacle during raising of the backrest.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, the arjo device failed to meet its specification since the side rail detached partially and the bed¿s frame was bent.There was a patient on the bed when the failures occurred.The complaint was decided to be reportable due to the safety side rail malfunction (one of the upper arms and lower arm detached).

• 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: 11692896
• MDR Text Key: 251671248
• Report Number: 3007420694-2021-00057
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05059441126201
• UDI-Public: (01)05059441126201(11)201012
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E5X2FC103BCASB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other