MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FIRST STEP TRICELL; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Decrease in Pressure (1490)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided when conclusions from the investigation will be available.

Event Description

Arjo was informed that a patient is complaining that the mattress is flat in the middle and it is hurting him as he in a lot of pain.The patient was on the mattress for 3 days.The pump was evaluated after the event.The blower was able to push the air to the mattress, but it did not meet manufacturer's specification regarding an air flow readings.Mattress was not evaluated as it was not identified.

Manufacturer Narrative

The investigation has been carried out to this complaint and the conclusions are following.On 10 july 2018, arjo was notified about an incident involving first step tricell system.It was reported that patient was sinking in the middle section of the mattress.The patient remained on a defective mattress for 3 days, until the system was replaced.There was no injury in relation to this event.The customer did not transfer the patient to another mattress because the backup mattress was used with another patient.According to the service technician who visited the customer the mattress was inflated and kept the patient's weight.However, when the air supply unit returned to the service center where was evaluated, it was found that the amount of pressure generated by the blower unit was insufficient.According to an arjo technician the air supply unit failed due to a worn internal blower.The mattress was not evaluated as it was not tagged for quarantine, therefore it is unknown if it functioned properly.Before the unit was rented to the customer it passed the quality control check, the pressure generated by the blower was in accordance to manufacturer's specification.The system was delivered to the customer in june 2018.First step tricell mattress and air supply unit were placed with the patient by the customer from storage.Product quick reference guide 212846-ah instructs caregivers about proper patient placement and regular care.During patient placement and regular check, a caregivers need to: "verify proper air pressure setting for patient size: - allow 40% depression or cradling effect in cushion where patient lies, - perform hand check by sliding hand flat between air mattress and air base.Verify 1 to 1.50 in of clearance beneath patient's buttocks." insufficient pressure is easily noticeable during the above activities.It is the responsibility of the caregiver to assess patient frequently and as soon as the fault is discovered, the patient should be moved to another surface.The blower failure itself is not considered reportable malfunction.The investigated event presents a scenario in which the patient was left on the defective mattress for 3 days, which is considered a risk factor that could compromise patient's safety.In summary, the first step tricell system was used for a patient treatment when the event occurred and therefore played a role in the incident.The system failed to perform its specification as an air supply unit failed due to a worn internal blower.When any product malfunction is detected, the product should be withdrawn from use until the service or replacement is performed.In the investigated case, the implement procedure of patient's care (patient remained on a defective mattress) has contributed to the reported event and could have compromised patient's safety.For this reason it was decided to report this incident in abundance of caution.

• Brand Name: FIRST STEP TRICELL
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 7749892
• MDR Text Key: 116050535
• Report Number: 3007420694-2018-00153
• 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: 09/27/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/05/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other