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

Model Number PXA001DAR

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received, it appears most likely that during assisting the patient to get out of bed the overlay mattress slipped off the bed causing the patient's fall.When reviewing similar reportable events, we have found 2 cases with similar general fault description patient fall from the mattress, however the occurrence rate observed for this failure mode is currently considered to be very low.It has been established that the auto logic 110 mattress overlay system was being used for patient handling at the time of the event and in that way contributed to the outcome of the event.There were no malfunctions reported and related to the pump.It was suggested that one of four holding straps of the overlay mattress was broken.The base cover for the mattress overlay has four adjustable corner retention straps which slide under the corners of the base mattress enabling the connection of the two surfaces.Based on the photographic evidences received we can clearly establish that one out of four holding straps was not attached/ not interlaced properly into grommet welded to auto logic overlay base.Therefore, it can be established that the strap had not been fitted over the bottom surface and adjusted properly before the incident took a place.From all information collected to date, we believe that the strap wrong attachment did not cause the reported problem, since the other three straps were found to be in place and holding the mattress from shifting.According to instruction for use (ifu) the overlay must be placed on top of the base mattress, not directly on the bed frame.Despite our best effort we did not manage to gain information whether the base mattress was placed underneath the auto logic overlay or not and if so, what was the product used.Therefore we cannot exclude the possibility of placing the auto logic mattress overlay on the bed frame as well as the fact that if any base mattress was placed the fixing straps have ever been attached to it.The defect of such fitting would be detected during installation and reported before the incident occur.Going forward, due to lack of information we were not able to establish whether the customer installed the mattress on their own or with an assistance of the rental technician.Based on the above evaluation we are not able to confirm that the correct mattress installation, according to product ifu, was performed.As an on site inspection showed that the system is working in accordance to specification it appears most likely that incorrect installation of the overlay mattress contributed to the event.The auto logic instruction for use (ifu) contains crucial information: "do not use the mattress overlay directly on the bed frame" "before using any of the auto logic mattress or seat systems make sure it has been installed correctly in accordance with "installation" " "secure the overlay to the base mattress by placing and tightening the four long straps under the corners of the base mattress." our evaluation appears to be in line with an installation error having occurred.When the ifu and the correct installation procedure would have been followed the event would have been avoided.The possible sequences of events presented above seems to be the most probable and to be in line with the event description.From the information available and our evaluation performed, we have come to find it most likely that the event was caused by incorrect installation of the auto logic overlay mattress.However, we are not able to confirm who installed the overlay mattress the rental technician or the customer despite on our best efforts.Arjohuntleigh suggests to remind the staff and service technician involved in the device installation, to pay attention to make sure that the mattress has been installed correctly before use.

Event Description

On 15 sep 2015 the following was reported to arjohuntleigh: on (b)(6) 2015 "the nursing staff were assisting the patient to get out of bed.As they did so the overlay mattress slipped off the bed causing the patient to fall off the mattress.The patient landed on his knee and grazed his knee.He was treated by the hospital nurse and then seen by a hospital doctor.All was fine.One of the four retaining straps on the mattress was broken.It is not clear whether this was already broken when the mattress fell or whether it was broken as an integral part of the incident.".

• Brand Name: AUTO LOGIC
• Type of Device: FNM
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ks. piotra wawrzyniaka 2; komorniki, PL62- 052; PL PL62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ks. piotra wawrzyniaka 2; komorniki, PL62- 052; PL PL62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore,; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5149659
• MDR Text Key: 28259159
• Report Number: 3007420694-2015-00196
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/14/2015,09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXA001DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2015
• Distributor Facility Aware Date: 09/15/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2015
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2010
• 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