MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O. O. ENTERPRISE 5000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number E5X3FA01CON5862

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Following the information provided after positioning the leg section of the bed it did not return to the horizontal position.Upon bed evaluation conducted by arjo technician it was confirmed that one of handset control buttons responsible for downward movement of the bed was not functioning sometimes causing un-commanded movement of the device.Moreover the calf section of the bed was not moving at all due to defective control box.There was no injury nor other medical consequences reported.

Manufacturer Narrative

This report is being filed under exemption e2012070 by arjohuntleigh polska sp.Z o.O.(registration#3007420694) on behalf of the importer arjohuntleigh, inc.(ahus) (registration#1419652).On 30-oct-2018 arjo received a customer complaint on enterprise 5000x beds.The customer claimed defective leg positioning on the newly delivered beds.Following the information provided by the customer in two cases after activating the leg section of the bed the device was not returning back to its horizontal position.After receiving the communication about the malfunction occurrence, arjo service technician was dispatched to conduct the device inspection.According to the information from technician only one bed (serial number: (b)(4)) was found to be defective.Upon bed's evaluation the control panel button was found to be defective (remained permanently activated).The technician noticed also that the bed was sometimes going spontaneously down without handset button activation.At the time the unintended bed movement occurred there was no patient lying on the bed.No injury nor other medical consequences were reported.In arjo service technician's opinion faulty handset was responsible for uncommanded bed movement occurrence however incorrect operation of the leg section of the bed (device not returning back to its horizontal positon) was caused by defective control box.The technician replaced both parts and returned the device back to use in working order.Both parts were returned back from market and send to the supplier for further evaluation.Supplier's analysis confirmed that the handset button was permanently activated due to internal damage.Visual inspection of the handset revealed visible signs of misuse -dents on housing, stressed cable.According to the supplier expertize, part's abuse has led to the internal switch damage and subsequently lack of proper functionality.The control box evaluation allowed to establish that one of the capacitors were shorted influencing functionality of the calf section of the bed.The supplier will monitor the failure rate.There are no further actions planned so far.It needs to be emphasized that the enterprise 5000x 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 (746-577 rev.14 ) includes information regarding the importance of correct handset storage in order to avoid its damage: "store the handset on the side rail using the clip on the back" although no injuries were reported in relation to this incident, the complaint was decided to be reportable due to the uncommanded bed movement occurrence and cautious approach.Upon the conducted investigation we were able to determine that the mechanical damage of the handset contributed to the unintended device movement occurrence.The device was reported to move on its own and from that perspective, the enterprise 5000x bed did not meet its performance specification.There was no patient lying on the bed at the time the auto-movement of the bed was experienced.

• Brand Name: ENTERPRISE 5000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O. O.; ks. wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 8115232
• MDR Text Key: 129312491
• Report Number: 3007420694-2018-00224
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097357218
• UDI-Public: (01)05056097357218(11)180925
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

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
• Device Operator: No Information
• Device Model Number: E5X3FA01CON5862
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2019
• Distributor Facility Aware Date: 10/30/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2019
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other