MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MINUET 2; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 160AA6A1A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is on going.Further information will be available in the next expected report.

Event Description

Following the information gathered, the right hand safety side detached from the bed frame.The arjo service technician refitted the part and the bed started to operate correctly.No injury was claimed.There was no indication of any patient involvement.

Manufacturer Narrative

The arjo service engineer during the onsite visit confirmed that the folding steel safety side disconnected from the bed frame on the head end of the bed.No components were found defective.This part is secured to the headboard using the attachment clamp screw and the spacer bar which is assembled behind the edge of the headend panel.It ensures the correct position on the bed.The spacer bar was disconnected due to the loosening of clamps and caused the side rail to hang off from one side and could not function as intended.The arjo service engineer refitted the part and the bed started to operate correctly.The last preventative maintenance was performed on nov 2023 and all the fastenings were fully tightened as per service manual (746-397-10): ¿examine the bed for obvious signs of damage.Make sure that all nuts, bolts and other fastenings are present and fully tightened.¿ the instruction for use (ifu 746-396-en) also warns the user to ¿check the screw clamps are fully tightened when using cm-acc06.52 and cm-acc07.52 (safety sides)¿¿ weekly.To sum up, the review of complaints revealed that the reported complaint is a singular occurrence (partial detachment found on the folding steel safety side).Arjo device was not used for patient treatment during the event.The device failed to meet its specifications when the side rail detached.The complaint was assessed as reportable due to the safety side detachment.

• Brand Name: MINUET 2
• 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
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18343914
• MDR Text Key: 330784540
• Report Number: 3007420694-2023-00299
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 160AA6A1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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