MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O ALPHA RESPONSE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 465001DAR

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Arjo was informed about a patient fall from alpha response mattress while attempting to get out of the bed.Customer stated that the event occurred when the patient needed to go to the toilet.It was reported that the patient sat on the edge of the bed and slipped out.

Manufacturer Narrative

Investigation has been carried out onto this complaint and conclusions are following.Arjo was informed about a patient fall from arjo alpha response mattress while trying to get out of the bed.There was no injury sustained as a consequence of this fall.This incident was not witnessed, however, it was reported that the client was sitting on the mattress to step out of bed, mattress deflated and patient slipped out.Specific patient medical condition was not provided by the complaint originator, nevertheless, arjo clinical specialist performing interview at the customer facility has classified patient as partly capable of performing daily activities independently, not generally physically demanding for the caregiver.Arjo personnel attended customer's site and changed the mattress.No faults were found with the replaced mattress.Arjo personnel reported device looking and working well, no technical faults were noticed.Upon investigation, it was reported that arjo technician correctly installed alpha response mattress.Straps were placed to secure the mattress to the bed frame and device set up was correctly adjusted to patient's weight.Evaluation of the arjo system did not indicate any failure that could contribute to the resident's fall.Bedframe information (i.E., brand name and characteristics) was not provided.However, it was reported that a bed was not in its lowest position but patient could touch easily the floor without stretching her legs or stepping up.The product user guide instruction for use (ifu) number 464933en_05 warns: "it is the responsibility of the care giver to ensure that the user can use this product safely." "whilst the patient is unattended, the decision to use safety sides should be based on clinical assessment and in line with local policy." after reviewing post market surveillance for alpha response system within a period of five years, by awareness date, it was found that the current incident is the first event that concerns patient fall from alpha response mattress.In conclusion, the arjo alpha response system (both mattress and pump) was used while the event occurred, therefore it played role in the event.The customer allegation of mattress deflation was not confirmed as device was found working as per manufacturer specification.The circumstances of the event, information regarding usage of bed frame remains unknown.Therefore, it is not possible to determine the exact root cause of patient fall.We report this event due to allegation of patient fall, which may lead to serious health consequences.

• Brand Name: ALPHA RESPONSE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 8820958
• MDR Text Key: 152061881
• Report Number: 3007420694-2019-00119
• Device Sequence Number: 1
• Product Code: FNM
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 465001DAR
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 64