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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported unintended movement was recreated during inspection performed by arjo representative.The results of the investigation will be provided to the follow-up report.
Event or Problem Description
Following information reported by (b)(6) in the us, the unintended movement of the backrest section of the enterprise 9000x bed was observed.No injury was reported.
Additional Manufacturer Narrative
Following information reported by the customer kindred hospital the palm beaches in the us, the backrest section of the enterprise 9000x moved unintended.It was not indicated whether the patient was lying on the bed when this issue occurred.There was no injury reported.Arjo service technician tested the bed at the facility and the reported malfunction was recreated.The device inspection confirmed that the backrest up button membrane on the integrated attendant control panel located on the outside foot-end side rail (patient¿s left-hand side) was torn.This part was replaced and functional testing confirmed the proper functionality of the bed.In summary, there was no indication that the involved enterprise 9000x was used with the patient when the backrest section moved unexpectedly.There was a button damaged on the patient 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: 9920104
• Report Number: 3007420694-2020-00067
• Device Sequence Number: 3257341
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190418
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/16/2020

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: 03/06/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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