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

Model Number E5X2QQ113DBAGB

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The simulations carried out by the manufacturer showed that two potential situations may lead to the reported issues (an unacceptable distance and frame damage) 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 5000x bed ((b)(4)).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 device analysis results, the exact cause of the reported issue could not be determined.In summary, the enterprise 5000x bed did not meet the manufacturer¿s specifications.No patient was lying on the bed when this malfunction was observed.The complaint decided to be reportable in abundance of caution because the unacceptable distance under specific circumstances may lead to the radius arm detachment.

Event Description

During inspection of the enterprise 5000x bed by the nurse, it was observed that the foot section of the bed was not level.This issue was observed before the patient was placed on the bed.There was no injury reported to arjo.Evaluation of the device performed by arjo technician revealed that the bed sub-frame was bent in a place where the backrest actuator is located.Due to the pressure applied between the backrest actuator and the base frame some signs of the backrest bracket weld failure were noticed.This also resulted in a gap in the area of the c-clip responsible for keeping the radius arm in place was noticed.

• 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
• 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: 10256244
• MDR Text Key: 198866334
• Report Number: 3007420694-2020-00112
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982747134
• UDI-Public: (01)05055982747134(11)170713
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: E5X2QQ113DBAGB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2017
• 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