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 Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

The process of reviewing and analysing all gathered information is ongoing.The results of the analysis will be provided upon conclusions from the investigation.

Event Description

Following information reported by (b)(6), the enterprise 5000x bed platform could not be lowered and raised during use with the patient.No injury was reported to arjo.The facility staff decided to place the patient on another bed and removed the defective bed from use.Arjo technician visited the facility and inspected the device.It was confirmed that the left head-end radius arm detached from the bed's frame and the radius arm on the opposite side was twisted.

Manufacturer Narrative

Following information reported by the caritas medical center in hong kong, the facility staff was unable to raise the enterprise 5000x when the patient was lying on the bed.No injury was reported to arjo.The facility staff decided to place the patient on another bed and quarantined the defective bed.Arjo technician visited the facility and inspected the device.It was confirmed that the left head-end radius arm detached from the bed's frame and the radius arm on the opposite side was twisted.The simulations carried out by the manufacturer showed that two potential situations may lead to the reported radius arm detachment.The first one when the backrest is blocked with an obstacle in the position of 45 degrees.And the second one when an obstacle is put between the base frame and radius arm.Based on testing results, it can be concluded that the reported malfunction cannot compromise a patient¿s safety if the bed is used according to the procedure described in instructions for use dedicated to the enterprise 5000x bed (ifu 746-577-uk-14).Ifu warns: "when the bed is operated, make sure that obstacles such as bedside furniture do not restrict its movement¿.Based on the limited information gathered, the exact scenario which led to the radius arm detachment could not be determined.In summary, the enterprise 5000x bed did not meet the manufacturer¿s specifications.The patient was lying on the bed when this issue was noticed.The complaint decided to be reportable in abundance of caution due to the malfunction of enterprise 5000x (radius arm detachment).'patient identifier' and 'customer phone number' were corrected.

• 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: 10269878
• MDR Text Key: 198866836
• Report Number: 3007420694-2020-00116
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982747707
• UDI-Public: (01)05055982747707(11)180605
• 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: 07/23/2020

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: Other
• Device Model Number: E5X2FC103BCASB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other