MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. ALPHA RESPONSE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 464EUR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abrasion (1689); Pain (1994); Physical Entrapment (2327)

Event Date 07/21/2021

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 the complaint including an allegation that the patient was placed on the alpha response during the night and at 7.45 in the morning was found by the caregiver trapped between the mattress and the bed side rail, unable to get out.The patient was lying on hit stomach with his face between the mattress and the bed rail on the wall side and his right leg was trapped between the mattress and the bed rail from mid-thigh to toe.The caregivers released the patient.

Manufacturer Narrative

Arjo became aware of a complaint with an allegation that a patient with parkinson was placed on an alpha response mattress during the night and at 7.45 in the morning was found by a caregiver trapped between the mattress and a bed side rail, unable to get out.The patient was lying on a stomach with a face between the mattress and the bed rail, and his right leg was trapped between the mattress and the bed rail from mid-thigh to toe.The patient was released by the customer staff.Reported outcome included: the slight big toe abrasion and possible upper leg muscle pain from lying in the same position for a long time.Following the event, the patient seemed to be very absentminded but in the course of the day his normal behaviour returned.He received a standard dose of paracetamol.No medical intervention was needed.The alpha response system was used on a standard bed frame equipped with the side rails.There was no report of arjo system malfunction.The patient has dementia and was not able to explain what happened.The customer speculated that the mattress did not fit the bed frame correctly (was too short in length and too narrow in width) what in connection with a very skinny patient contributed to the event.This hypothesis could not be verified as dimensions of the bed frame are unknown.According to alpha response instruction for use (464933en), ¿the mattresses can be used on standard hospital and normal domestic beds.¿ there is also warning, ¿alignment of the bed frame, safety sides and the mattress should leave no gap wide enough to entrap a patient's head or body (¿) care should be exercised to prevent occurrence of gaps by compression or movement of the mattress.Death or serious injury may occur.¿ arjo devices (mattress and pump) were used for patient treatment when the event occurred and from that perspective played a role in the event.The customer has not reported an arjo device failure.The complaint was decided to be reportable due to the patient's entrapment which may result in serious injury.

• Brand Name: ALPHA RESPONSE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 12323847
• MDR Text Key: 266648926
• Report Number: 3005619970-2021-00016
• 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: 08/26/2021

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: Health Professional
• Device Model Number: 464EUR
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 60