MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP.Z O.O. MINUET 2; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 161AN8A1U

Device Problem Entrapment of Device (1212)

Patient Problem Bruise/Contusion (1754)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 arjohuntleigh has been initially notified about an incident that involves minuet 2 bed.It was indicated that resident was found on the floor on the right side of the bed with her left arm cradling her head between the mattress and side rail.Resident had either slid down the bed or had moved during sleep.The right side of her face would have been pressed against the side rail.Staff found her and lifted her back into bed.As a result of the incident the patient sustained slight bruising on right side of cheek and below jaw.

Manufacturer Narrative

This report is being filed under exemption e2012070 by arjohuntleigh polska sp.Z.O.O.(registration # (b)(4)) on behalf of the importer (b)(4).On 2017-jul-20 arjohuntleigh was informed about an incident involving minuet 2 bed.It was reported that the patient (b)(6) years old female weighting (b)(6) kg classified as patient incapable of performing daily activities independently or actively contributing in any substantial or reliable way, slipped out of the left side of bed and trapped her head between side rail and mattress.The right side of her face was pressed against the side rail.As a consequence the patient suffered slight bruising on right side of check and below jaw.The staff lifted and positioned the patient back into a safe lying position on the bed.According to the additional information provided we established that the bed in question is not under arjohuntleigh service contract.The date of last device maintenance remind unknown.Arjohuntleigh's minuet 2 electric bed was evaluated at the customer facility by an arjohuntleigh representative who assessed the overall condition of the bed as good and was not able to find any malfunction which could have led to the event.Based on information provided by the facility representative the patient was restlessness and constantly moving what would suggest that resident's behavior could be the contributing factor to the entrapment occurrence.According to the additional information provided we stablished that side rail used with claimed bed by the time of the incident was safety side model number cm-acc23 (egress assist rail extra height).The mattress used with this bed was evolve - 203.2 mm height.It needs to be pointed out that according to the current product instruction for use dedicated to minuet 2 bed (746-396-ca-11) the maximum recommended thickness of mattress that may be used with safety side cm-acc23 should be 172mm height.The above review is proving that non-conforming mattress was used with the bed in question.Based on product instruction for use "when choosing the bed and mattress combinations, it is important to consider the use of safety sides based on clinical assessment of each individual patient and in line with local policy".Safety sides are additional accessory which is recommended, however should not be used with restless patients as hyperactivity creates the possibility of ease body entrapment.The current product instruction for use (746-396-ca-11), informs the user how to properly use the device to ensure the patient and caregiver safety.It also contains a general warnings and cautions, including those which warns about entrapment hazard and proper patient assessment: "before operating the bed, make sure that the patient is safely positioned to avoid entrapment or imbalance." "entrapment hazards may exist when using a very soft mattress, even if it is the correct size." "side rails must always be used with a mattress of the correct size, which is approved for use with this bed"."the clinically qualified person responsible should consider the size, age and condition of the patient before allowing the use of side rails".Basing on the information gathered, are not able to fully determine the circumstances which have led to the patient's entrapment, however based on the above we can conclude that although arjohuntleigh devices played a role in the event, as it was used for the patient treatment when the event occurrence, it has not failed to meet its manufacturer's specification.We were able to exclude bed malfunction.Taking into consideration health condition of the involved patient (restlessness, moving constantly), we conclude that this factor might have led to the unfortunate issue and minor injuries (slight bruising on right side of check and below jaw).Due to the nature of this incident we are reporting this event to competent authorities based on the allegation of patient's entrapment and the minor injury sustained.

• Brand Name: MINUET 2
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP.Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP.Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6796615
• MDR Text Key: 82761028
• Report Number: 3007420694-2017-00175
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 161AN8A1U
• 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: 09/28/2017
• Distributor Facility Aware Date: 07/20/2017
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/28/2017
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2012
• 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 Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 61