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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The process of analyzing all gathered information is ongoing.Additional information will be provided upon the conclusions of the investigation.
Event or Problem Description
On (b)(6) 2020 arjo was informed that the backrest section of the enterprise 9000x moved unintended without any actions given by the user.There was no patient on the bed when this issue occurred and no injury was reported.
Additional Manufacturer Narrative
Following information reported by the customer kindred hospital mansfield in the us, the backrest section of the enterprise 9000x raised unintended without any actions given by the user.This issue was observed when the facility staff was cleaning the bed.There was no patient on the bed when this issue occurred and no injury was reported.The device evaluation confirmed the reported problem and it was noticed that backrest up button located on the attendant control panel (outside right foot-end side rail) did not function properly, causing the backrest section to move even when the button was released.This part was replaced and functional testing confirmed the proper functionality of the bed.In summary, the involved enterprise 9000x was not used with the patient when the backrest section moved unintended.There was a malfunctioning button on the attendant control panel detected, therefore the bed did not meet the manufacturer¿s specifications.Although no injury was reported, the complaint decided to be reportable in an abundance of caution due to unintended backrest movement.

• Brand Name: ENTERPRISE 9000X
• Common Device Name: 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: 10166984
• Report Number: 3007420694-2020-00101
• Device Sequence Number: 2318355
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190508
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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
• Operator of Device: No Information
• Device Model Number: 9611AF101BCUSB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other