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

Model Number E5X2FC103BCASB

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The results of the investigation will be provided to the follow-up report.

Event Description

Following information reported by (b)(6) hospital in (b)(6), a caregiver's finger got hurt when operating the side rail of the enterprise 5000x bed.This injury required closure with sutures.

Manufacturer Narrative

Following information reported by (b)(6) hospital in hong kong, a caregiver's finger got hurt when operating the split side rail of the enterprise 5000x bed.This laceration required closure with sutures.After this event, the bed was evaluated by arjo representative.The visual inspection did not reveal any device malfunction.The functional test confirmed that the bed was working properly, as per manufacturer specifications.Based on the information collected during meeting with the facility staff the caregiver pinched her finger while lowering the safety side not according to the procedure given in the instructions for use (746-577-en-16).During raising the safety side rail, the caregiver placed her finger between moving components- the safety side rail mechanism and plastic panel.The enterprise 5000x has four side rails, two on each side of the bed.These side rails are equipped with a handle which allowed to raise the safety side.The safety side rail operation procedure is described in instructions for use dedicated to enterprise 5000x bed: to raise the side rail: ¿hold either side rail handle.Pull the side rail up and away from the bed until it locks in the raised position with the audible ¿click¿.Additionally, ifu warns that the side rail contact points are identified by the warning symbol and it indicates that user should keep his hands and fingers away from these areas.Following these operation procedures and warning is mandatory for the safe use of the bed.In summary, upon the conducted investigation we have confirmed that none of available information indicates that the device failed to meet its specification.The event occurred while the caregiver was raising the side rail therefore arjo bed played a role in the reported event.There was no indication that the device was used with a patient at the time of this event.Based on the performed investigation, it seems most likely that an adverse event occurred in relation to caregiver operating technique being not in line with instruction given by the manufacturer.The complaint was decided to be reportable to competent authorities based on the outcome ¿ laceration requiring closure with sutures.

• 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
• MDR Report Key: 9494508
• MDR Text Key: 175837781
• Report Number: 3007420694-2019-00228
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982747707
• UDI-Public: (01)05055982747707(11)190618
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: E5X2FC103BCASB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention