MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED. AB MINUET 2; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number ZSRENGB00270

Device Problems Collapse (1099); Unintended System Motion (1430)

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

Event Date 09/12/2023

Event Type  malfunction  

Event Description

It was claimed by the customer that the minuet 2 side rail was defective.It was lowering unexpectedly without any undue force required.The bed was in use with the patient during the malfunction occurred.No injury was reported.

Manufacturer Narrative

Investigation is on-going, further information will be available in follow-up report.

Manufacturer Narrative

It was claimed by the customer that the minuet 2 side rail was defective.It lowered unexpectedly without any undue force required during use.The patient was on the bed at that time.No injury was reported.The arjo service engineer during an on-site visit checked the device and confirmed the unexpected release of the left-hand side rail.The claimed minuet 2 is equipped with two side rails each made of three metal pipes.The metal pipes side rails are made of 3 main elements: a backing plate connecting a side rail with a bed frame; a plunger connected with the backing plate which is used to move the side rail in an up or down position, and metal pipes that provide a barrier for the user in bed.Following the device inspection results, the issue was related to the side rail plunger being loose from the backing plate.The loosening was a result of the accumulation of dust and grime.It prevented the plunger from fitting properly and caused the side rail not to lock as intended.The engineer cleaned the dust and grime and adjusted the locking bolt.The side rail started to operate correctly.No other issue was found during the visit.Sum up, based on the above findings, the most likely cause of the issue is associated with normal use/ wear of the product during years of usage.Arjo device failed to meet its performance specification since unexpected open of the safety side occurred.Arjo device was used for patient treatment when the event occurred.The complaint was assessed as reportable due to an allegation concerning the side rail unexpectedly releasing during use since it may lead to a fall.No injury occurred.

• Brand Name: MINUET 2
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED. AB; unit 3 britannia park, trident drive; wednesbury WS10 7XB; UK WS10 7XB
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED. AB; unit 3 britannia park, trident drive; wednesbury WS10 7XB; UK WS10 7XB
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17903697
• MDR Text Key: 325253946
• Report Number: 3007420694-2023-00246
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ZSRENGB00270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2007
• 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