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

Model Number 161AN8A1CA

Device Problem Entrapment of Device (1212)

Patient Problem Physical Entrapment (2327)

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information gathered the patient right leg was put through the opening in the side rail.The circumstances are remain unknown.The facility stated that the patient has cognitive impairment and it appears she may have been attempting to get out of bed.

Manufacturer Narrative

The arjo was informed about the reported incident by health canada on 21 nov 2023.An onsite visit was arranged to evaluate the claimed bed.The visit did not reveal any device failures.According to the photographic documentation, the bed was in use with the non-arjo mattress.This mattress dimensions are not recommended by the manufacturer.However, it is concluded that the type of mattress used with the bed is not related to this particular event as the patient was not stuck between the mattress and the side rail.The side rail type used with the bed was a metal pipe.The instruction for use (ifu ) indicates that: "side rails are not intended to restrain patients who make a deliberate attempt to leave the bed." based on the provided information the root cause of the investigated situation could be related with the patient's medical condition and patient's attempt to leave the bed.Arjo device was used for a patient treatment when the event occurred and from that perspective, it played a role in the event.The device did not fail to meet its specification as no malfunction of the device was observed.The complaint was assessed as reportable in abundance of cautions due to allegation of patient body entrapment.

• 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: 18354597
• MDR Text Key: 330872184
• Report Number: 3007420694-2023-00300
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982785426
• UDI-Public: (01)05055982785426(11)180824
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• 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: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 161AN8A1CA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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
• Patient Sex: Female