MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. TRIADYNEPROVENTA; BED, PATIENT ROTATION, POWERED

Model Number 406000

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/05/2023

Event Type  malfunction  

Manufacturer Narrative

The bed inspection confirmed the reported issue, the device was replaced and inspected.The main factor which could lead to the side rail detachment might be related to an excessive force applied to the side rail.This is in line with side rail condition, revealed by the photographic evidence (the side rail was detached from the bed's frame).Sum up, the external excessive force must first compromise the integrity of the safety side prior to detachment.Arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.Arjo device failed to meet its performance specification since the side rail detachment occurred.No injury occurred.The claimed issue upon reoccurrence may contribute to the patient fall therefore the complaint was assessed as reportable.

Event Description

Arjo was informed about an event involving triadyne proveta bed.According to the information provided, the left side rail detachment occurred when the bed was in use by a patient.No injury occurred.The bed was taken out of use.

• Brand Name: TRIADYNEPROVENTA
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 17008891
• MDR Text Key: 316001670
• Report Number: 3007420694-2023-00112
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/26/2023

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
• Device Operator: Other
• Device Model Number: 406000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/26/2023
• 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