MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. MINUET

Model Number 161AA8A1A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

Initially we were informed that the safety side has fallen off the bed.Based on the additional information provided it has been confirmed that the resident was in bed at the time of event.Patient has been checked by the night staff, who attended to him at the beginning of the shift.Ten minutes later they checked on him again and found that one of the cot side rails, had dropped onto the floor.The resident was still in bed and fortunately, no injuries were reported in relation to the event.

Manufacturer Narrative

(b)(4).When reviewing reportable events for minuet beds range we were able to establish that there have been few similar complaints for side rail falling off the bed.There is no trend observed for this failure mode.The product involved in the incident is a minuet 2 bed, model 161aa8a1a, serial number (b)(4), which was manufactured on 2015-02-18.The device history record has been reviewed and no anomalies were found.In this particular complaint, due to the limited information provided, arjohuntleigh was not able to obtain the actual model type of the involved safety side.However, based on the photos provided, it was established that those were: a full length wooden cot sides.These type of safety sides are an optional accessory, suitable to be used with the minuet bed.The safety side consist two wooden boards, connected to the head and foot end frame of the bed by a guide channel, in which the wooden boards were moving up and down during raising or lower the rails.The device involved in this incident was inspected at the customer site by an arjohuntleigh representative.The technician assessed the overall condition of the bed frame as very good and confirmed that before his arrival the complete cot side had been taken off the bed frame.He assembled and refitted it to the bed, and noticed that the catch button on one side was missing.The purpose of the catch button is to lock the side rail in the up position, therefore, when this part is broken or missing, one side of the safety rail will not stay in the locked position.Unfortunately, it is unk if the catch button was missing before the incident or if it was lost as a result of the side rail collapse.Moreover, the technician could not duplicate the claimed issue - properly installed cot side did not fall on the floor, even with the catch button missing.The product instructions for use (ifu #746-396_12 dated on march 2014), which was supplied with the device involved in the event, inform the user how to properly assemble and operate the side rails, furthermore operation of the safety sides should be checked weekly by the user of the device.Unfortunately, despite of arjohuntleigh company best efforts, the information if ifu recommendations have been followed was not provided.In summary, when the incident occurred the device has been used for patient treatment, therefore it played a role in the event.The device has failed to meet the manufacturer spec and, although there were no injuries reported, it was decided to assess this complaint as reportable to competent authorities based on the potential for injury.Due to the fact that the safety side (a subject of this complaint) has not been quarantined after the incident, the exact root cause of this failure could not be established.Given the circumstances and the fact that there is no trend observed for this failure mode, arjohuntleigh shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: MINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4932662
• MDR Text Key: 6039123
• Report Number: 3007420694-2015-00138
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/16/2015,06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 161AA8A1A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2015
• Distributor Facility Aware Date: 06/19/2015
• Device Age: 0 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/16/2015
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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: 53 YR
• Patient Weight: 58