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

Model Number 9X22BW111BCAGB

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 30-nov-2018 arjo received a customer complaint involving enterprise 9000x.The reported malfunction took place in the (b)(6) hospital in (b)(6).Following the information provided the backrest section of the bed moved up without any button being pushed neither on hand control nor control panel while the bed was being moved between wards.At the time the unintended bed movement allegedly occurred there was a patient lying on the bed.No injury nor other medical consequences were reported.After receiving the communication about the malfunction occurrence, arjo service technician was dispatched to conduct the bed's inspection with regards to the alleged issue.During bed's evaluation the technician was not able to confirm reported malfunction, claimed failure could not be recreated.All bed's functions were working as per manufacturer's specification.According to the information provided by the facility staff there was no obstruction near control panel that would unintentionally activate control panel buttons.Moreover it remained unknown if the control panel lockout function was activated at the time of the reported scenario.The bed in question was not under arjo service contract, the last device maintenance was conducted on 21-jun-2018.It needs to be emphasized that the enterprise 9000x bed (serial number: (b)(4)) was checked before being distributed to the customers to verify if the product meets the required manufacturer's specifications and check whether the acceptance criteria are met.Records of the inspection are documented in the device history record (dhr).The device history record has been reviewed for this specific device and no anomaly was found.To ensure the safety of our products the instruction for use provided together with the involved device (746-591 rev.4 dated on jul 2015) includes information regarding the possibility of activating the beds function without the intention and how this situation can be avoided: warning: "it is recommended to use the function lockout facility on the attendant control panel to prevent unintended movement in situations where objects may press against the patients' controls", warning: " store the handset on the side rail using the clip on the back; this will help to prevent accidental operation of the controls", warning: "take care not to squeeze or trap the handset cable between moving parts of the bed," warning: "the controls require only a single press to activate.To prevent unwanted movements of the mattress platform, avoid leaning against the side rails and keep equipment on and around the bed clear of the controls," information: "function lockout can be used to prevent operation of the controls, e.G.When inadvertent movement of the mattress platform could injure the patient." although no injuries were reported, the complaint was decided to be reportable due to alleged uncommanded bed movement occurrence and cautious approach.Upon the conducted investigation and bed inspection done by the arjo representative, we were unable to determine the exact root cause of claimed failure.The reported malfunction could not be recreated.The device was reported to move on its own and from that perspective, the enterprise 9000x bed did not meet its performance specification.

Event Description

On 30-nov-2018 arjo received a customer complaint involving enterprise 9000x.The reported malfunction took place in the (b)(6) hospital in (b)(6).Following the information provided the backrest section of the bed moved up without any button being pushed neither on hand control nor control panel while the bed was being moved between wards.At the time the unintended bed movement occurred there was a patient lying on the bed.No injury nor other medical consequences were reported.

• Brand Name: ENTERPRISE 9000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O. O.; ks. wawrzyniaka 2; komorniki, 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O. O.; ks. wawrzyniaka 2; komorniki, 62052 ; PL 62052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 8173082
• MDR Text Key: 131802007
• Report Number: 3007420694-2018-00235
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2018,11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9X22BW111BCAGB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Distributor Facility Aware Date: 11/30/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other