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

Model Number 161AA8A1A

Device Problem Entrapment of Device (1212)

Patient Problem Physical Entrapment (2327)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

Arjo was notified by a trust district nurse about an incident involving a community patient who was using the minuet 2 bed frame and the nimbus 3 mattress.It was reported that the patient¿s leg was entrapped in the bed frame side rail.The emergency services were called to assist with releasing the patient¿s limb.The bruising and abrasion on the patient's knee were reported as outcome of this event.The patient refused transport to the hospital and wanted to stay at home as the patient was at end of life.

Manufacturer Narrative

Arjo was notified by a trust district nurse about an incident involving a community patient who was using the minuet 2 bed frame and the nimbus 3 mattress.It was reported that the patient¿s leg was entrapped in the bed frame side rail.The emergency services were called to assist with releasing the patient¿s limb.The bruising and abrasion on the patient's knee were reported as an outcome of this event.The patient refused to be transported to the hospital and wanted to stay at home as the patient was at the end of life.The claimed minuet 2 bed frame was equipped with two side rails (one on each side of the bed).Each of the side rails was built of 3 metal bars.In the reported case, the patient¿s leg was entrapped between the side rail bars.The bed was inspected and tested by an arjo representative.The arjo service technician did not find any issues, all functions worked correctly.The technician only tightened a screw, that had been removed by someone at the time of releasing the patient's limb.The minuet 2 bed frames are compliant to standard iec 60601-2-52, which specifies the requirements for trapping zones within the bed.The optional side rails pads were available at the patient¿s home but were not used.The district nurse informed that she found the side rail pad under the bed and recommended the user to install it.In her opinion lack of use the side rail pads contributed the patient¿s entrapment.Minuet 2 instruction for use, (id.746-296 uk_11) includes information on how to install the side rail pads ¿fasten the five velcro strips to secure the pad to the safety side.The diagram shows the safety side pats fitted to full length wooden safety side.Use a similar method when fitting the pads to full length steel safety sides (¿).¿ ¿before operating the bed, make sure that the patient is safely positioned to avoid entrapment or imbalance.¿ ¿the clinically qualified person responsible should consider the size, age and condition of the patient before allowing the use of safety sides.¿ arjo device failed to meet its performance specification since the patient trapped the leg between the device parts.The device was used for patient¿s treatment when the event occurred.This complaint is deemed reportable due to the allegation of entrapment of the patient's limb.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15370180
• MDR Text Key: 305715547
• Report Number: 3007420694-2022-00143
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 161AA8A1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2013
• 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 Age: 86 YR
• Patient Sex: Male
• Patient Weight: 66 KG