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

Model Number 406000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Arjo became aware of a complaint, alleging that the patient fell out of the triadyne proventa bed and passed away.

Manufacturer Narrative

Arjo became aware of a complaint on triadyne proventa bed.The customer¿s allegation was that the patient fell out of the bed and passed away.No further information regarding this event are available.Based on the available information it is not possible to determine the root cause of this fault.The functional check of the device both before and after renting this device to the customer did not reveal any malfunctions of the device.The user manual for the triadyne proventa bed (406019-ah rev.C) informs the user to take into consideration the potential risk of falling by the following statements: ¿consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed (.)¿; ¿to minimize the risk of falls or injury, the unit should always be in the lowest practical position when the patient is unattended¿; ¿side rails must be in the full upright and locked position before rotation.¿ 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 was performing as intended.No malfunction was found during the device evaluation.This complaint is deemed reportable due to allegation of patient's fall out of the bed resulting in patient's death.

• Brand Name: TRIADYNEPROVENTA
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 12238155
• MDR Text Key: 263814882
• Report Number: 3007420694-2021-00107
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 406000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death