MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. BARIMAXX II; FNL

Device Problem Component Falling (1105)

Patient Problem Laceration(s) (1946)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for the range of barimaxx devices, we have been able to find only one complaint with the fault descriptions where part of the trapeze assembly support fell off on the patient.In that case, there was no injury reported.There is no trend observed for reportable complaints with this failure.Trapeze system is an optional accessory suitable to be used e.G.With the barimaxx ii device, it is an overhead rail system with a suspended handle to aid patient in repositioning, sitting, exiting and entering the bed.In the course of this investigation we have been able to established the following: during trapeze installation by a service consultant, the rear support weldment detached from the post and allegedly swung cutting patient's foot, the cut was determined as not a serious and required just a bandage, the patient has a skin condition that is easy to rip, the trapeze installation was completed after the event with the assistance of a male nurse, in summary, the device failed to meet its specifications as it was being used at the time of the event for patient treatment, and due to this played a role in the incident.Possibly as a result of the event, patient suffered minor cut to the foot.It seems most likely that the device failed due to an oversight during trapeze installation.Given the circumstances it has been recommended to performed a training to the service consultant about safety assembling the trapeze.

Event Description

Arjohuntleigh was informed about an incident that took place on (b)(6) 2016 around 6:35 pm at a facility site: (b)(6).A service consultant was installing a trapeze assembly at the foot end of a barimaxx bed frame when the cross bar (rear support weldment) that holds the two post (column weldment) slipped off the upright post and it swung across cutting the patient's foot.According to the service consultant the mattress was pushing against the post in a way that the construction became unstable.A nurse confirmed that the cut on the patient's foot was not serious and just required a bandage.According to the nurse the patient has skin issues on his feet so the skin is easy to rip.The installation of the trapeze assembly was completed by the service consultant and another male nurse that was in the room.

• Brand Name: BARIMAXX II
• 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: 5965918
• MDR Text Key: 55215643
• Report Number: 3007420694-2016-00199
• Device Sequence Number: 1
• Product Code: FNL
• 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
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/21/2016,08/22/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2016
• Distributor Facility Aware Date: 08/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/21/2016
• 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