MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. PENTAFLEX; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number 150SL210/086

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

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch reports is submitted under arjohuntleigh polska sp.Z o.O.Establishment name and registration (b)(4).Additional information will be provided when investigation conclusion is available.

Event Description

An elder person living with dementia and parkinson's desease was found on the floor.The fall was not witnessed, it happened overnight.No defect was found within arjo mattress.Bed side rails were in their low position.

Manufacturer Narrative

Arjo was informed about 7 patients falls from arjo pentaflex mattress (medwatch reports numbers 3007420694-2019-00173, 3007420694-2019-00179, 3007420694-2019-00182, 3007420694-2019-00189, 3007420694-2019-00190, and 3007420694-2019-00191).Incidents occurred at a healthcare facility located in netherlands taking care of elderly people with dementia.On (b)(6) 2019 a patient (female, 82 years old, weight 42 kg) was found on the floor in her room.The patient stated that she slipped out of bed.The fall was not witnessed.There was no injury.Following the customer fall risk protocol, the bed frame used (stiegelmeyer model bett elvido-vano, type 188222) had side rails lowered.Additionally, an alarm device was placed near the bed to alert caregivers in case patients exit the bed.In the investigated event, the customer staff reacted on the alarm when patient exited the bed.An arjo pentaflex mattress was inspected by arjo representative who did not find a fault.The patient had parkinson and dementia disease and was described as being unrest in the night, therefore the fall most likely was related to her medical state and not arjo mattress.To sum up, arjo mattress was used for patient treatment during the reported fall and therefore played role in the event, but did not failed to meet its specification (there was no product failure).The patient fall was most likely related to her medical state.We report this event due to patient fall from arjo mattress.

Manufacturer Narrative

The facility's intervention protocol for high risk fall patients is to place side rails in the lowest position and an alarm device is placed near the bed, which alerts caregivers about patient exiting the bed.In the complaint the caregivers reacted on an alarm.When conclusions from the investigation are available, a final report will be provided.

• Brand Name: PENTAFLEX
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 9237814
• MDR Text Key: 198507961
• Report Number: 3007420694-2019-00180
• Device Sequence Number: 1
• Product Code: IKY
• 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,Followup
• Report Date: 12/03/2019

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: Lay User/Patient
• Device Model Number: 150SL210/086
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/02/2019; 10/02/2019
• Supplement Dates FDA Received: 11/22/2019; 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 42