MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. BARIMAXXII; FNL

Model Number 310400

Device Problems Device Issue (2379); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc (under registration #1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881.From 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 #307420694.When reviewing similar reportable events for barimaxx family range, we have found three complaints with the allegation that patient fell from the bed due to brake failure.However, detailed complaints review revealed that none present the same scenario, where due to worn castors a partial slippage was indicated to have occurred when brakes were applied.There is no trend observed for reportable complaints with this failure for barimaxx devices.The product involved in the incident is a barimaxxii; serial number: (b)(4), model number: 310400.The device is part of the arjohuntleigh us rental fleet.The device was rented to the customer, (b)(6) hospital.The event occurred during the transfer of the patient from one bed to the other.It was stated the despite that the brakes were in locked position the bed moved and as a consequence the patient fell in between two beds.There was no injury sustained as a result of this event.The bed was delivered to the facility the same day the event occurred.The evaluation performed in the service center, revealed that two castors located on foot end of the bed were slightly worn which could be considered as potentially creating partial slippage when brakes were applied.The brakes held when force was used to move the bed back and forth, however when the side to side motion was applied the slippage occurred.The bed was checked in accordance to quality control checklist on 3 oct 2016, before the bed was placed at a customer site and no anomalous conditions were found.The brakes were working as intended.Performed root cause analysis using ishikawa diagram revealed that inappropriately performed bed maintenance by a technician cannot be ruled out as a potential root cause.However, since it cannot be excluded a re-training has been proposed to re-train the involved technician.Please note, also that upon reviewing complaints in our complaint handling system we have not found any other complaints that would indicate any other similar errors.In summary, the device failed to meet its specification as it was confirmed that the castors located on foot end of the bed were slightly worn creating partial slippage when brakes were applied.It was being used when the event occurred and therefore, it contributed to the event since the patient fell from the bed.There was no injury sustained as a result of this event.This event has been decided to be reportable based on the potential and in abundance of caution as the patient fall may result in harm of high severity.Given the circumstances and the number of similar events, this incident appears to be an isolated one.We shall continue to monitor for any further events of this nature and do not propose any further action at this time (except the proposed re-training to the involved technician).

Event Description

Initially, a nurse called requesting another bed to be delivered stating that barimaxxii is not appropriate for a patient.On (b)(6) 2016, the bed was swapped and at that moment arjohuntleigh representative was notified about the incident that took place on (b)(6) 2016 at approximately 16:00.It was stated that during patient transferred from a regular intensive care icu bed to a rental barimaxx bed, the barimaxx moved and the patient (female, weight (b)(6)) fell in between the two beds.According to the device operators, the 4 castor brakes were in lock position.Patient was picked up from the floor and placed on the bed with aid of a hard surface transfer board.

• Brand Name: BARIMAXXII
• Type of Device: FNL
• 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: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6075196
• MDR Text Key: 59134724
• Report Number: 3007420694-2016-00228
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/03/2016,10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310400
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2016
• Distributor Facility Aware Date: 10/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• 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
• Patient Weight: 159