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

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Physical Entrapment (2327)

Event Date 10/27/2016

Event Type  Death  

Manufacturer Narrative

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)(6)'s complaint handling establishment and any medwatch reports will be submitted under registration #307420694.Additional information will be provided upon conclusion of the investigation.

Event Description

On october 30, 2016 arjohuntleigh was informed about the incident that took place on (b)(6) 2016 in (b)(6) hospital.It was reported that patient (male) got caught in bed (barimaxx ii with maxxair ets, (b)(4)) and somehow got strangled to death.The bed has not been released back to arjohuntleigh from the customer site, yet.The hospital has secured and is holding the bed per their investigation.

Manufacturer Narrative

(b)(4).Additional information will be provided within 3 month from the date of this report.

Event Description

We would like to inform that till the date of this report, the bed has not been released back to the service center for evaluation from the customer site.It is worth noting that both products barimaxx ii and maxxair ets passed all quality control requirements in august 2016.The last time the facility was contacted in regards to this event took place on (b)(6) 2017, without a success.

Manufacturer Narrative

(b)(4).Arjohuntleigh received information regarding an adverse event reported by the nurses that the male patient "got caught in the bed somehow and strangled to death".The circumstances of the incident, the patient's condition, and weight have not been made available to arjohuntleigh by the customer despite the legally mandated requests.The product involved in the incident is barimax ii bed which was used in combination with maxxair ets mattress replacement system (mrs).The devices are part of the arjohuntleigh us rental fleet and were rented to the customer rochester general hospital.Both devices that played role in the event were not released for arjohuntleigh inspection till 7th february 2017.The devices were returned to the service center and evaluated in accordance with the quality control checklist, both barimaxx ii bed frame, and maxxair ets mattress passed the manufacturer's requirements.Apart from bodily fluids found on the patient deck and the head board, no deficiencies were identified.A review of complaints for barimaxx and maxxair product family from the past allowed us to establish that this incident is a single, isolated case.The barimaxx ii therapy system is designed for bariatric patients with maximum weight of 1000 lb (455 kg).Width of the patient surface can be expanded while the patient remains on the bed.The bed frame was being used with maxxair ets mattress replacement system, which is a pressure relief therapy system principally for barimaxx ii bed.The mattress replacement system is designed for patient weighing up to 1000 lb (453,5kg), with expandability features from 36 in to 42 in to 48 in in width.User guide for barimaxx ii therapy system e.G.310611-ah rev.A dated on september 2013 and user guide for maxxair ets e.G.310115-ah rev.B dated on august 2014 warn that use or non-use of siderails or other restrains can be critical to patient safety; serious injury or death can result from the use or non-use of side rails such as potential entrapment or patient fall.The documents indicate also to monitor patient frequently to guard against patient entrapment as the specialty surface may have different shear and support characteristics than conventional surfaces and may increase the risk of patient movement into hazardous position of entrapment.It has been indicated in the user guides that "whether and how to use side rails or restraints is a decision that should be based on each patient's needs and should be made by the patient and the patient's family, physician and caregivers, with facility protocols in mind.Caregiver should assess risks and benefits of side rail/restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs [.]".The barimaxx ii bed was evaluated to the standard for medical and dental equipment ul-544 in 2000.The evaluation did not include entrapment testing, however the barimaxx active frame, which has the same siderail design and patient surface has the designed verified.Please note that since barimaxx active consists of a bed frame from barimaxx ii with upgrades for 60601 compliance, it has been concluded that "rationale for the acceptance of barimaxx active not complying with all aspects of the en 60601-2-38: 1996 guidelines related to protection against patient entrapment" from 2010, is applicable to barimaxx ii bed frame as well.The rationale was based on guidance "hospital bed system dimensional and assessment guidance to reduce entrapment" provided by the fda.The guidance indicates standard side rail dimension in products based on the average adult and not a bariatric adult.The bariatric beds and pressure-reduction products have been excluded from the scope of the guidance as anthropometric data has not been used in determining the recommended dimensional limits of the entrapment zones in this guidance.As per the rationale, the bariatric patients are at a lower risk of entrapment than small, lightweight patients and frail/confused patients.With the limited information available to us we 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 specifications.We were able to exclude both frame and mattress malfunction.Due to the fact that arjohuntleigh product has been directly involved in the event we report it based on patient outcome.

• Brand Name: BARIMAXX II WITH MAXXAIR ETS
• 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: kinga stolinska ; 12625 wetmore, ste 308; ks. wawrzyniaka 2; komorniki,, TX 62-05-2 ; PL 62-052 ; 2103170412
• MDR Report Key: 6123928
• MDR Text Key: 60745171
• Report Number: 3007420694-2016-00240
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2017; 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death