MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. FIRST STEP SELECT; FNM

Device Problems Device Operates Differently Than Expected (2913); Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjohuntleigh has been informed that patient has slide out of the mattress, most likely first step select, but did not suffer any injury.

Manufacturer Narrative

(b)(4).From november 2012 through october 31, 2014 medwatch reports related to complaints of this product were submitted under registration (b)(4).From november 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).On july 1st 2016, arjohuntleigh has been informed that the customer requested a mattress that has bolsters on the side.Note that such bolsters are in fact additional pieces of mattress that act as cushions at the mattress sides, to help prevent falls or migration to the side rails.The nurse mentioned that the patient had slid out but was not hurt.Despite multiple attempts to reach out initial reporter was made, no response from the facility was received.When reviewing similar reportable events for first step select, we have found a limited number of cases with similar fault description.In none of these cases, any product malfunctions were confirmed.This mattress is part of arjohuntleigh us rental fleet and it is checked before and after each hire.Quality control sheets from before and after use at this customer do not indicate any malfunction of the device.There is also no information about what bed was used with the mattress and whether the side rails were in up position at the time of the event.Responsible care must be taken when using any part of a device that comes into contact with a patient or user.In conclusion, there is no indication that the first step select device failed.It was most likely used for patient's treatment and this way it contributed to the event.Having that limited information available we cannot establish the root cause of the event occurrence.No action is deemed necessary at this time.Shall any additional information become available in the future, the investigation will be updated.

• Brand Name: FIRST STEP SELECT
• Type of Device: FNM
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5821690
• MDR Text Key: 51246399
• Report Number: 3007420694-2016-00156
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/29/2016,07/01/2016

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2016
• Distributor Facility Aware Date: 07/01/2016
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/29/2016
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• 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): Other