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

Model Number	9814DF101BCUSB
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The analysis of all gathered information is ongoing.Additional information will be provided upon conclusions of the investigation.
Event or Problem Description
Following information reported, the enterprise 9000x bed lowered unintended, when the right side rail was lowered.No patient involvement and no injury was reported to arjo.
Event or Problem Description
Following information reported, the enterprise 9000x bed platform lowered unintended, when the right side foot-end side rail, which was placed in the lowered position, was gently moved by a caregiver.No patient involvement and no injury was reported to arjo.
Additional Manufacturer Narrative
Following information reported, the enterprise 9000x bed platform lowered unintended, when the right side foot-end side rail, which was placed in the lowered position, was gently moved by a caregiver.No patient involvement and no injury was reported to arjo.The evaluation of the device carried out by an arjo representative recreated the reported symptom.The device evaluation revealed that there was an electrical failure of the side rail wiring (cross-continuity problem) that caused the reported unexpected bed movement.The foot-end side rail 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 bed moved unintended.There was an electrical failure of the wire inside the side rail 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 the unintended bed platform 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: 10275336
• Report Number: 3007420694-2020-00117
• Device Sequence Number: 2697783
• Product Code: FNL
• UDI-Device Identifier: 05055982755207
• UDI-Public: (01)05055982755207(11)181020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/12/2020

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: 9814DF101BCUSB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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