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

Model Number 227500-R

Device Problems Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 04/28/2017

Event Type  Death  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc (under registration#1625774).From (b)(6) 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc.And any medwatch raports were submitted under registration #3009988881.From november 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.When reviewing reportable events for first step family range, we have been able to find some complaints with the same effect: patient falling off the mattress and/or bed.However, there is no one, particular scenario or sequence of events that leads to the patient unintentional exit from the mattress surface.There is also no similar scenario to the investigated case - patient fall from the device during personal care when turning feature is activated and not all side rails are in raised position.There is no trend observed.The mattress involved in the incident is first step all in one serial number (b)(4).The device was sold to (b)(6) centre over 5.5 year ago.The mattress was placed on a non-arjohuntleigh frame - stryker bed frame (stryker go; serial number (b)(4).The first step all in one mattress replacement system is an advanced low air loss therapy system with unique automated pressure redistribution to help manage skin microclimate, friction, shear, maintain tissue viability in high risk residents/patient and edema for high acuity patients.The system offers three selectable therapy levels, each offering a specific grouping of therapies and features to help caregivers manage multiple conditions in high acuity patients.One of the therapy level is a turning feature, which provides a continuous lateral turning of patients on the air surface to a turn angle of approximately 20 degree.The complaint was that the patient fell from the bed the moment the nurse turned away from the patient to reach something from behind.In a result the resident sustained scrape on right forehead, bump on right back side of head, a subdural hematoma and passed away on (b)(6) 2017.Additional information provided was that the mattress was placed on a non arjohuntleigh bed frame (stryker bed frame - stryker go; serial number (b)(4)).The head section was raised to 30 degree.The patient was provided a personal care and was prepared to a transfer to a wheelchair.Only one nurse assisted in the patient care.According to the nurse, the turning feature was on, the patient fell from the side when the side rail from head section was raised.When the patient was left unattended, was placed supine slightly on left side.First step all in one user manual # 227688-ah rev.B cautions that " prior to engaging turn feature, ensure that bed frame has side rails and that all side rails are fully engaged in their full upright and locked position"."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." additional information provided was that the distance between top of side rails and top of mattress (without compression) was 3.5 inch and top of rail to base of mattress was 6 inch, whereas according to the user manual "safety information" section the distance shall be approximately 8.66 inch between the top of side rails and top of mattress to prevent inadvertent bed exit or falls.After the incident the patient had post-fall protocol applied, which includes assessing for loss of consciousness, airway, breathing and circulation, assessment of head-to-toe for injuries, assessment of vital signs and neurovital signs.In case of no serious injury is found on assessment, and the fall was unwitnessed, the patient is transferred off floor, and nursed to assess vital and neurovitals signs.With this patient, the treatment included neuro check, vitals, monitoring, ice packs on bruise.It was confirmed that no ct scan (computerized tomography) or mri scan (magnetic resonance imaging) was performed after the incident which would allow us to establish the cause of this critical consequence for the patient.First step all in one was inspected on site and no defects were noted regarding the mattress functioning, no observable wear and tear.Firmness was at the maximum setting at the time of inspection.Taking above into account it seems that the patient fall was a result of insufficient attention given during patient's personal care: the resident was left unattended on the mattress with turning feature on, only one side rail at the head section was raised (styker go bed has four side rails, two on each side), mattress was not compatible with the bed frame (the proper distance, which might prevent from a fall, between side rail and mattress was not ensured).After the event the facility followed the post-fall protocol, however no ct scan or mri scan was performed.The post fall treatment included neuro check, vitals, monitoring and ice packs on bruise.In conclusion, there has been found no failure within the first step all in one system that could have caused or contributed to the event occurance.The mattress was being used for patient treatment and placed on the non arjohuntleigh bed frame, therefore it played a role in the event.We believe that the cause of the problem was not following precautions by health professionals during procedures performed on the patient.The complaint was decided to be reportable based on the information of patient fall and critical outcome of the incident.

Event Description

Arjohuntleigh was notified about the incident that occurred (b)(6) 2017 with first step all in one mattress.A patient ((b)(6)) fell from the bed and in a result sustained scrape on right forehead, bump on right back side of head, a subdural hematoma and passed away on (b)(6) 2017.It was reported that a nurse was providing care to the patient in side, lying on the mattress with head of bed raised to 30 degrees.When a turned away from patient to reach for something behind her, patient was unattended, and the patient rolled off the bed.It was stated that a patient medical condition was stable.The care involved washing and dressing the patient to prepare th patient to be transferred to a wheelchair.

• Brand Name: FIRST STEP ALL IN ONE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 6645161
• MDR Text Key: 77684291
• Report Number: 3007420694-2017-00143
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/15/2017

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: Nurse
• Device Model Number: 227500-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 75