MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. MAXXAIR ETS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 310800

Device Problems Human Factors Issue (2948); Device Handling Problem (3265)

Patient Problem Tissue Damage (2104)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of complaints for the last 5 years revealed that there are two complaints where the issue with a mattress not inflating was reported, however only one (investigated here) relates to situation in which patient developed unstageable tissue damage allegedly due to one or more mattress cells not connected to an air hose manifold.Therefore, it has been concluded that the investigated event is the first one with the described problem.Taking into account 8594 placements within the last 2 year (data available from january 2015 till december 2016), and comparing it to the number of reportable complaint, it can be stated that the complaint rate is significantly low.The product involved in the incident is maxxair ets mattress replacement system (mrs), model #310800.It is a customer-owned device, sold to (b)(6) medical center.The serial number for the device was not provided by the customer also the device could unfortunately and despite our best efforts not be inspected by an arjohuntleigh representative after the event since the facility did not recognize the issue as a malfunction and did not see the necessity for the inspection.The allegation was that the patient developed a pressure ulcer as a result of cells being not inflated.The patient, age (b)(6), male, (b)(6), who was placed on the mattress has been a paraplegic for 29 years with no sensations from the nipples down.The patient had present upon admission multiple severe pressure ulcers.The mattress was connected with three hoses of the mattress to barimaxx ii bed by a hospital staff members.Within 72 hours, a new area of deep tissue injury was identified on the patient's buttock.Upon mattress inspection by the customer, it was noticed that some cells were not connected to an individual connection of an air hose.The customer stated that the connection are located out of view, the cells are out of view also by the opaque covering and there is no alarm that would bring staff attention to this condition.Additionally, it was stated by the customer that the issue could have occurred when the product was set up after cleaning where not all connections for the hoses might have been secured.The facility itself does not consider the issue as a product malfunction.After cell connection was set, the mattress worked as intended and remained in further use.User's guide for maxxair ets e.G.310115-ah rev.B informs to monitor skin condition regularly and consider adjunct of alternative therapies for high acuity patients.The document guides through the steps of patient placement, including ensuring that the air hoses are connected to the pump, monitoring patient airway and positioning during inflation/deflation of a mattress, adjusting the air pressure and verifying the air adjustment with hand check, verifying patient comfort and air pressure adjustment with patient in both sitting and side lying positions.The troubleshooting section of this guide describes procedure that are to be provided if a specific symptom occurred, such as "one or more cells do not inflate", the possible cause can be that cells are not properly connected to hose set and the remedy is to properly connect air manifold to cell.Even if some cells would be disconnected, the verification of air pressure in accordance to user's guide, as described above, would allow a caregiver notice the failure and act appropriately minimizing the possibility of occurrence of any hazardous situation.Alleged new area of pressure ulcer however, has been noticed after 72 hours.A caregiver, during patient placement performed other activities "in addition to the initiation of other pressure ulcer preventative nursing interventions".It seems that the incident was related to a caregiver being incautious during patient placement, also the mattress, which is intended for a larger patient may have been improperly selected for a smaller patient.Please note, that the system capabilities are designed for large patients weighing up to 1000lb (453.5 kg), which body mass is greater than 40 bmi (body mass index).In the complaint at hand patient's weight was (b)(6), which is below that index.In summary, the device does not fail to meet its specification, after the appropriate connection of the cells was established the device worked properly.However looking at the incident scenario it has been established that maxxair ets was being used for patient treatment at the time of the event and in that way contributed to the adverse event - patient developing an unstageable pressure ulcer.Please note, that situation where an air hose is disconnected from one or more cells is not considered to be a hazardous situation by itself.This type of situation on its own does not constitute the basis for complaint to be reportable.If user follows all of the guidelines given in user's guide the probability of any dangerous situation occurrence is diminished to minimum.If any malfunction are discovered before the usage, the device has to be excluded from use and cannot be used again.Basing on the above, it can be concluded that there are several factors which might contribute to patients outcome: pre-existing health state, improper preparation and verification of a mattress surface during patient placement, monitoring not properly adjusted to the patient's condition, improperly selected mattress for smaller patient.In this particular case there was no mattress malfunction and taking into consideration all the circumstances of the reported event, the most likely root cause is related to a caregiver not following the instruction presented above and may be defined as use error.This event has been decided to be reportable due allegation of unstageable pressure ulcer and not product malfunction.Given the circumstances that the incident is most likely related to a caregiver not following instruction provided in user's guide and taking into account that this type of issue is the first one with the reported event problem, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Arjohuntleigh received a communication from food and drug administration (fda) on 28th december 2016 and later on 3rd january a voluntary medwatch report from (b)(6) medical center, which was submitted to the competent authority (report mw5066596) in relation to the incident which involved maxxair ets mattress.The allegation was that the patient developed pressure ulcer as a result of mattress cells being not inflated.The patient had present upon admission multiple severe pressure ulcers.It was stated that some mattress cells were not connected to an individual connection of an air hose.The customer communicated that the issue could have occurred when the product was set up after cleaning where not all connections for the hoses might have been secured.

• Brand Name: MAXXAIR ETS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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 ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6282296
• MDR Text Key: 65897369
• Report Number: 3007420694-2017-00018
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/27/2017

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: Health Professional
• Device Model Number: 310800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Weight: 56