MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 9X22BW111BCAGB

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Arjo received a call requesting to service and repair the enterprise 9000x owned by new royal adelaide hospital located in (b)(4).There was no information regarding patient involvement.No injury was reported.When an arjo technician visited the customer, the bed was quarantined.Evaluation of the device performed revealed that there was a gap in the area of the c-clip responsible for keeping the radius arm in place and the frame was bent in the middle section of the bed.The simulations carried out by the manufacturer showed that two potential situations may lead to the reported issues (an unacceptable distance and frame bend) and consequently to 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 itself cannot lead to the radius arm detachment and bed collapse and if the bed is used according to the procedure described in instructions for use dedicated to the enterprise 9000x bed (ifu 746-591-en-3).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 provided and unknown circumstances in which the issue occurred, the exact cause of the reported issue could not be determined.In summary, the enterprise 9000x bed did not meet the manufacturer¿s specifications.There was no information regarding patient involvement forwarded to arjo.The complaint decided to be reportable in abundance of caution because of unacceptable distance and bend frame.

Event Description

Arjo received a call requesting to service and repair the enterprise 9000x owned by new royal adelaide hospital located in (b)(4).There was no information regarding patient involvement.No injury was reported.When an arjo technician visited the customer, the bed was quarantined.Evaluation of the device performed revealed that there was a gap in the area of the c-clip responsible for keeping the radius arm in place and the frame was bent in the middle section of the bed.

• Brand Name: ENTERPRISE 9000X
• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 10325140
• MDR Text Key: 200505938
• Report Number: 3007420694-2020-00123
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9X22BW111BCAGB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other