MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000A; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number KA9APREVG3580

Device Problems Use of Device Problem (1670); Human Factors Issue (2948); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

It was reported that a patient fell out of bed.According to daughter, her mom lays to the edge side regularly and side rail was down.The resident was using atmosair9000a mattress with the invacare frame bed.

Manufacturer Narrative

Additional information provided: the patient used a wheelchair and a ceiling track lift for transport.It is unknown why the bed side rails were in down position and if the patient was left unattended when fell.According to an arjohuntleigh technician, who initially inspected the system, the shell foam of the mattress had raised sides, the sat system seemed to be hyper inflating and alternating air in the cushions was very minimal with the maximum setting.After additional checking, it was stated by the technician that the sat system seemed working properly.There was no holes or leaks in the cushions.The pump was tested per quality control sheet and was working correctly.No defect was detected.Further testing showed that both sides of the foam mattress raised only 1.5 to 2 inches off the table with no patient (as per design).The technician indicated also that when a 170lb volunteers was placed on the mattress, it seemed to stay inflated.When the technician set the pump to half way the mattress adjust to the internal pressure setting controlled by the relief valve after 10 to 15 mins, but the technician indicated that it still seemed firm.Because further testing is required as at this point we cannot confirm nor exclude product defect, we are organizing a shipment of the system to the contract manufacturer.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Arjo was notified that the female patient fell out of the bed.The patient's daughter stated that "the patient lays to the edge side regularly" and that the side rail was down.Arjo atmosair9000a mattress was installed on non-arjo invacare bed frame when the incident happened.The patient was hospitalized with a fracture.No further details were provided due to patient privacy.Additional information was that, the patient used wheelchair and a ceiling track lift for transport.It is unknown why the bed side rails were in down position and if the patient was left unattended when fell.The atmosair 9000a and a pump were evaluated, first by arjo technician and then by arjo contract manufacturer.An arjo technician indicated that the sat system seemed to be hyper inflating and alternating air in the cushions was very minimal with the maximum setting and that the foam raised on the corners, yet when the sat system was checked it seemed working properly.The pump was tested and was working correctly.No defect was detected.Because, the initial inspection was inconclusive and it was not possible to confirm nor exclude product defect, mattress and pump were sent to arjo contract manufacturer for further testing.Arjo contract manufacturer provided tests results on 7th jun 2018.Technical evaluation revealed that apart from cover showing signs of wear (this is not related to the investigated case), no defects were found.The system operated as per specification, no excessive pressure was identified.It was observed that when the mattress was unpacked and placed on the table, the sat system inside was slightly over-inflated and the mattress was slightly raised on both sides.The foam along the patient left side rail was softer than the patient right side rail.But when the trapped air was released from the system the mattress returned to its static mode height.The atmosair 9000a is a hybrid mattress built of sat cells (made of foam) and encompassed by top foam layer.The sat cells are a higher profile than the foam shell, therefore it is normal mattress behavior to have raised sides.From the evaluation performed, it can be stated that there is no evidence that would indicate that the atmosair 9000a mattress could in any way contribute to the fall.User manual 407384-ah rev d warns: - "warning: use or non-use of restrains, including side rails, can be critical to patient safety.Serious or fatal injury can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restrains." in safety information section user manual states: - "side rails / patient restraints: whether and how to use side rails or restrains is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocol in mind.[.] 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 and from patient entrapment in or around the side rails, restraints or other accessories.[.] consult a caregiver and carefully consider the use of bolsters, positioning aids or floor pads, especially with confused, restless or agitated patients.It is recommended that side rails (if used) be locked in the full upright position when the patient is unattended " - "bed height - to minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended".In the complaint at hand, information provided by the patient's daughter indicates that the side rails were not used for unknown reason and that the patient regularly laid to the edge of the bed.This on its own creates a hazardous situation.When reviewing complaints for patient fall for atmosair product range we have found limited number.In summary, the mattress was being used for patient treatment at the time of the event and in that way played a role in the event outcome.The mattress did not fail to meet its performance specification, the resident fall was not a result of mattress failure but most likely because the safety protocol was not followed by the customer.We report this incident because of the resident fall and serious injury sustained.

• Brand Name: ATMOSAIR 9000A
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• MDR Report Key: 7302744
• MDR Text Key: 101242139
• Report Number: 3007420694-2018-00050
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: KA9APREVG3580
• Device Lot Number: 05041502
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 02/14/2018; 06/07/2018
• Supplement Dates FDA Received: 03/29/2018; 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization