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

Model Number E5X1DC11ABAEB

Device Problems Mechanical Problem (1384); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

After evaluation of the enterprise 5000x bed claimed by the life (b)(6) private hospital in (b)(6), it was confirmed that the bed's frame was bent and unacceptable distance between the retaining clip assembled on subframe spigot and bearing assembled into radius arm was noticed.The radius arm did not detach from the bed frame and the bed did not collapse.There was no indication regarding patient involvement.No injury or other medical consequences reported.The analysis of this problem carried out by the manufacturer revealed that the radius arm would not detach when the bed is handled in accordance with the instruction for use.The simulations showed that two potential situations can lead to this malfunction.The first one when the backrest is locked with the obstacle e.G.Windowsill (in the position of 45 degrees) and pushed till the actuator limits, then the bed is gently pulled by the foot section of the bed leading to the radius arm detachment.And the second one when the obstacle is put between the base frame and radius arm.Based on that, it can be concluded that the reported malfunction (unaccepted distance) itself cannot lead to the radius arm detachment and bed collapse and cannot compromise a patient's safety unless there is additional factor such as obstacle which restricts bed movement.Additionally, it should be emphasized that the instructions for use dedicated to the enterprise 5000x bed (746-577-uk_13) include information and warnings, which are mandatory for the safe and effective use of the bed, including the safety of patients and caregivers.It indicates that: "when the bed is operated, make sure that obstacles such as bedside furniture do not restrict its movement".If this warning is followed, there is no risk for the radius arm detachment.Due to the limited information gathered, the exact cause of this malfunction could not be determined.It was not possible to determine whether the way in which the bed was used could contribute to the reported malfunction.In summary, the enterprise 5000x did not meet the manufacturer's specification.There was no indication regarding patient involvement at the time the malfunction occurred.The complaint decided to be reportable due to the fact that the unaccepted distance under specific circumstances (described in the section above) may lead to the radius arm detachment and bed collapse.

Event Description

After evaluation of the enterprise 5000x bed claimed by the life (b)(6) private hospital in (b)(6), it was confirmed that the bed's frame was bent and unacceptable distance between the retaining clip assembled on subframe spigot and bearing assembled into radius arm was noticed.The radius arm did not detach from the bed frame and the bed did not collapse.There was no indication regarding patient involvement.No injury or other medical consequences reported.

• Brand Name: ENTERPRISE 5000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 9361222
• MDR Text Key: 198510415
• Report Number: 3007420694-2019-00203
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982749312
• UDI-Public: (01)05055982749312(11)180109
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E5X1DC11ABAEB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other