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

Model Number E5X2HC103DAAAA

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

The defective bed was removed from service and quarantined in arjo service center.The analysis is ongoing.The results will be provided upon conclusions from the investigation.

Event Description

Following information gathered, the foot end and head end radius arms dislodged from the enterprise 5000x bed's channels on the base frame and as a result, the lifting support arms were bent.There was a patient on the bed when this issue was observed, however no injury was reported.

Manufacturer Narrative

Following information gathered, the radius arms of the sub-frame dislodged from the enterprise 5000x bed's base frame.This was a consequence of disconnected stabilizer arms, which if connected, prevents the radius arms from being pulled out of the base frame.An arjo representative observed during the device inspection that the roller buffers were damaged with cracks visible.There was a patient on the bed when this issue was observed.No injury was reported.In the arjo technician¿s opinion, the poor bed condition with visible component failures may indicate that the bed was mechanically damaged, for example during transfer of the bed within the facility.However without the first level evidence, the exact cause could not be determined.In summary, according to the results of the enterprise 5000x bed evaluation, this device did not meet the manufacturer¿s specifications.There was a patient involved when this malfunction was observed.The complaint decided to be reportable in an abundance of caution due to the reported malfunction- detachment of the sub-frame from the base frame.

• Brand Name: ENTERPRISE 5000X
• Type of Device: 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: 10390004
• MDR Text Key: 202525577
• Report Number: 3007420694-2020-00137
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097313887
• UDI-Public: (01)05056097313887(11)190417
• 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: 08/27/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: E5X2HC103DAAAA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 63