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 investigation is ongoing.The results of the analysis will be provided upo conclusions of the investigation.

Event Description

Following information reported by the end user, the enterprise 5000x bed was damaged.There was a patient involved.No injury was reported.During inspection performed by arjo service engineer it was found that the backrest hinge was broken into half, the side rail upper arm detached and the bed frame and backrest were bent.The customer informed that the damages occurred because the patient raised the backrest without noticing that it is blocked.

Manufacturer Narrative

The analysis of all gather information is still ongoing.The results of the analysis will be provided to the follow-up report.

Manufacturer Narrative

Following information reported by the end-user, the enterprise 5000x bed was damaged.The patient was on the bed.No injury was reported.During inspection performed by the arjo service engineer, it was found that the backrest hinge broke in half, the side rail lower arm detached and the bed¿s frame bent in the middle and head section.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 failures occurred.The enterprise 5000x bed did not meet the specification during the event.The complaint was decided to be reportable due to the bed¿s malfunctions (side rail lower arm detachment, backrest hinge breakage).

• 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: 11663445
• MDR Text Key: 251671383
• Report Number: 3007420694-2021-00056
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982747707
• UDI-Public: (01)05055982747707(11)180725(21)
• 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,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other