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

Model Number	9611AF101BCUSB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following information reported by (b)(6), there was a problem with enterprise 9000x.More details were not provided by the customer.The evaluation of the device performed by an arjo technician revealed that the safety side rail detached from the bed frame.There was no indication regarding patient involvement.No injury or other medical consequences were reported.The review of post-market surveillance data and the investigation carried out at the manufacturer side revealed that the main factor which could lead to the safety side detachment might be related to an excessive force applied to the safety side.This is the most probable scenario, however, without having first-level evidence, the exact cause of the malfunction could not be determined.To sum up, the safety side rail was detached from the safety side rail mechanism, and from that perspective, the enterprise 9000x did not meet the performance specification.There was no indication regarding patient involvement at the time the malfunction occurred.The complaint was decided to be reportable due to the safety side rail detachment.
Event or Problem Description
Following information reported by (b)(6), there was a problem with enterprise 9000x.More details were not provided by the customer.The evaluation of the device performed by an arjo technician revealed that the safety side rail detached from the bed frame.There was no indication regarding patient involvement.No injury or other medical consequences were reported.

• 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: 10238777
• Report Number: 3007420694-2020-00108
• Device Sequence Number: 14053111
• Product Code: FNL
• UDI-Device Identifier: 05055982755030
• UDI-Public: (01)05055982755030(11)190425
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/07/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/07/2020
• 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