MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. AUTO LOGIC; FNM

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Contusion (1787); Fall (1848)

Event Date 09/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the patient's therapy on auto logic mattress caregivers have heard a noise which made them look for the source of it.The patient was found to be laying non the floor next to the bed, with a pillow under his head and the bed sheet around him.Bed fences were in use during the incident.As a result of this event the patient has suffered from a hip and right shoulder contusion.Pain medication was applied, no other medical intervention was required.It was indicated that patient's condition has contributed to the outcome of this event - patient had a deep wound exudate, with rectal intestinal bleeding.Due to this condition he was experiencing peak pains, reacting restless and angrily - throwing his legs over the bed fences and waving his arms.Bed fences were in use during the incident.The mattress was found to be in a good condition.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Following the information reported, a patient has fallen out from the bed when laying on the auto logic mattress.The facility has installed the mattress on the bed by themselves.It was reported that caregivers have heard a noise which made them look for the source of it.The patient was found to be laying non the floor next to the bed, with a pillow under his head and the bed sheet around him.Bedfences were in use during the incident.As a result of this event, the patient has suffered from a hip and right shoulder contusion.Pain medication was applied, no other medical intervention was required.When reviewing similar reportable events on auto logic system, it was possible to determine that this is the first complaint presenting a scenario in which patient's condition has contributed to the fall.The occurrence rate observed for this failure mode is currently considered to be very low.Following the information gathered, that patient's condition has contributed to the outcome of this event - patient had a deep wound exudate, with rectal intestinal bleeding.Due to this condition he was experiencing peak pains, reacting restless and angrily - throwing his legs over the bedfences and waving his arms.Bedfences were in use during the incident.The mattress was inspected and found to be in a good condition, being up to specification.Claimed mattress was installed on a non-arjohuntleigh bed and it was indicated that the distance between bedbottom and the upside bedfence was 34 cm.The distance between the level of auto logic mattress and to upper bedfence was 14 cm.The device instructions leave it for the caregiver staff to evaluate case-by-case whether such a distance is sufficient, especially for individuals (with e.G.Uncontrolled spontaneous movements of body) requiring a special medical attention.As an immediate action the facility decided to place additional foam mattress on the floor in order to eventually secure the patient.The suggestion on the change of therapy was made - it was proposed to use another arjohuntleigh mattress (therakair) instead of auto logic as it may reduce the height and would suit patient's therapy in terms of benefits provided by the system.The reason for the bed exit could be inadvertent however it appears unlikely for the patient to make an inadvertent jump from the bed of 14 centimeters upwards and a meter sideways, to land in the way described.It appears more likely there was intent by the patient to leave the bed.Side rails are not designed to keep patients in beds against their will, they are there to prevent unintentional exits of passive patients.Possible sequence of events presented above seems to be the most probable and in line with the event description.Basing on the information available, it was found that the event was most likely caused by use error - incorrect evaluation and handling of the patient condition as highlighted per the instructions for use having contributed to the incident.Due to the nature of this incident we are reporting this event to competent authorities in the abundance of caution - even though no serious injury occurred, there was a probability of harm with a high severity.It has been established that the auto logic system was in use for a patient therapy at the time of the event but from our review we did not find the direct indication that it contributed to the outcome of the event.Based on the above, the device was found not to have malfunctioned (was performing up to the specification) when the event took place.

• Brand Name: AUTO LOGIC
• Type of Device: FNM
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6036546
• MDR Text Key: 57728221
• Report Number: 3007420694-2016-00211
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physical Therapist
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/09/2016,09/13/2016

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2016
• Distributor Facility Aware Date: 09/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2016
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 64 YR
• Patient Weight: 75