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

Model Number 161AA4A1A

Device Problems Detachment Of Device Component (1104); Misconnection (1399)

Patient Problems No Consequences Or Impact To Patient (2199); Physical Entrapment (2327)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

Initially we have been informed that on the evening of (b)(6) 2015 the staff nurse heard the buzzer activate in the patient's room.Whenever she arrived she found the patient lying under the lower cotside.Half of the patient's body was still on the bed frame and the other half was resting on the crash matt.The patient was repositioned and fortunately, there were no injuries sustained as a result of the event.On closer inspection it was found that the 2 lower cotside screws were missing which allowed the patient to slide under the cotsides onto the floor.This is being reported as if this type of malfunction were to recur it may cause or contribute to a serious injury.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

During review of reportable events for the minuet beds we were able to establish that there are few complaints on patient entrapment, however, none of them represents the same root cause as the one investigated.Moreover one additional reportable complaint on side panel screw being loose, and resulting in a hazardous situation for patient and/or user, was found, however, the complaint is covering problem with different model type of safety panel.In summary, we were not able to find any additional similar complaints, no trend is observed.The product involved in the incident is a minuet 2 bed, serial number (b)(4) which was manufactured on 01/05/2012.The device history record has been reviewed, no anomalies were recorded at the time of manufacture.The safety side panels are an optional accessory for minuet 2 bed, and in case of claimed bed, the device was ordered with side panels.No cm-acc06-1 as an accessory.It is also worth noting that at the time of the incident, the bed was in use for over 3 years and arjohuntleigh was not aware of any other problems with this devices prior to the incident.In addition to the description of the event initially received, it was established that the cot sides did not fell off the bed and remained in the up and locked position.Due to the missing screws the side support had parted from the bedframe at the bottom leaving a gap which allowed the patient to slip through the side panel and the bed frame.The model of side panel used with the device during the incident is cm-acc00-1, therefore not the one originally ordered with bed frame.The design of the full length wooden safety sides allows to assemble or disassemble the sides to the bed frame, depending on the actual customer need.The safety side fixing bracket must be attached to the underside of each end panel with two m8 x 16mm socket head screws.The instruction of how to install the panel to the bed is clearly described in the instruction for use (ifu), provided with each device.There is also a warning in place to ensure that the screws are assembled and tightened correctly.The arjohuntleigh representative, who visited the facility, was not able to evaluate the original screws, since they were missing.Moreover non-arjohuntleigh screws are being used to secure the side support after the incident which could influence the utility of the safety side the arjohuntleigh representative checked the bed frame and safety side and was not able to find any anomalies.The technician also noted that there are only two sets of side rails used within the customers facility and these are fitted when required.Due to this fact it is possible that the parts are getting wear, which might result in a situation when they cannot be assembled and/or tightened properly anymore.Upon the arjohuntleigh visit, the facility has not been able to provide a preventive maintenance schedule and was not able to indicate the date of last preventive maintenance activities.In summary, when the event occurred the device was being used for the patient treatment, therefore it played a role in it.It has been confirmed that the device failed to meet the manufacturer specification, however the exact root cause of the issue could not be established.Upon the performed investigation, it seems most likely that the root cause of this event is a combination of few factors from which each is found to related to the user handling procedure.Although no injuries were reported in relation to this event, the complaint was decided to be reportable based on the potential.Given the circumstances and the fact that there is no trend observed for customer complaints with this failure mode, we shall continue to monitor further events of this nature and do not propose any further actions at this time.

• Brand Name: MINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4905503
• MDR Text Key: 17220154
• Report Number: 3007420694-2015-00130
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Risk Manager
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 161AA4A1A
• 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: 07/29/2015
• Distributor Facility Aware Date: 06/10/2015
• Device Age: 3 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/29/2015
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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 Age: 81 YR