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

Model Number E5X3BC006ABATB

Device Problems Collapse (1099); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 2018-nov-22 arjo was notified about a complaint involving enterprise 5000x bed.Following the information reported during up/down movement of the bed the radius arm detached from bed's frame causing bed's collapse.There was no patient lying on the bed at that time.There was no injury nor other medical consequences reported.Upon bed evaluation conducted by arjo technician it was confirmed that although the malfunction occurred, the c-clip securing radius arm was still in place.The visual inspection revealed that there was no distortion visible in the middle section of the bed, however the urine rail was bent indicating the device was raised/lowered against some obstacle.No signs of misuse on area of radius arm were noted.The technician repaired the device and left in facility in working order.The device was manufactured in aug 2016, there was no issue with radius arm detected within over last 2 years.The device history record has been reviewed for enterprise 5000x bed (serial number: (b)(4)) and no anomaly was found that would affect bed's stability.It is also worth noting that the enterprise 5000x bed has been designed, produced and certified to meet the requirements of standard iec 60601-2-52.This confirms that the beds are stable devices while used accordingly to product instruction for use.The post market surveillance data analysis allowed us to establish that radius arm while correctly assembled may detach only while subjected to some external forces.Summarizing, the findings made during the device did not allow us to establish the exact cause of the malfunction occurrence.Although there were no injuries reported, the complaint was decided to be reportable due to the allegation of the radius arm and bed's collapse.The radius arm detached from bed's frame and from that perspective, the enterprise 5000x bed did not meet its manufacturer's specification.

Event Description

On 2018-nov-22 arjo was notified about a complaint involving enterprise 5000x bed.Following the information reported during up/down movement of the bed the radius arm detached from bed's frame causing bed's collapse.Although the malfunction occurred the c-clip securing radius arm was still in place.There was no patient lying on the bed at the time of the incident.There was no injury nor other medical consequences reported.

• 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, ; PL
• 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: 8184067
• MDR Text Key: 131902560
• Report Number: 3007420694-2018-00244
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: E5X3BC006ABATB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2018
• Distributor Facility Aware Date: 11/22/2018
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/20/2018
• Date Manufacturer Received: 11/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other