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

Model Number	161AN8A1U
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is ongoing.No final conclusions are available at this time.
Event or Problem Description
A customer representative reported to arjo that a minuet 2 side rails are faulty.A strap connecting bars from which side rail was made broke.As a result, the side rails collapsed and detached of the rail holders.There were no indication that the issued occurred at time for use the bed by a patient.No injury was reported.
Additional Manufacturer Narrative
A customer representative reported to arjo that a minuet 2 side rails are faulty.A strap connecting the side rail bars broke.As a result, the side rail collapsed and detached of the rail holders.There were no indications that the issued occurred at time of use the bed by a patient.No injury was reported.The claimed bed was equipped in full length side rails which consist of two bars (upper and lower) connected by the straps located inside the rail holders.In received complaint the strap connecting the bars broke from unknown reason.It resulted in the lower bar full detachment and upper bar detachment at one end of the bed frame.According to instruction for use (746-396) an operation of the side rails should be weekly checked by the caregiver.Sum up, the side rail bars detached from the rail holders therefore the bed was not meeting to its specification.There was no allegation that the issue occurred at time of use the bed by a patient.No injury was reported.
Additional Manufacturer Narrative
Analysis of collected information is ongoing.An investigation conclusions will be provided as soon as the investigation will be completed.

• Brand Name: MINUET 2
• Common Device Name: 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: 11796316
• Report Number: 3007420694-2021-00067
• Device Sequence Number: 17038174
• Product Code: FNL
• UDI-Device Identifier: 05055982755597
• UDI-Public: (01)05055982755597(11)180705
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2021

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
• Operator of Device: No Information
• Device Model Number: 161AN8A1U
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 04/14/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/07/2021; 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other