MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. TRIADYNEPROVENTA; BED, PATIENT ROTATION, POWERED

Model Number 308900-CD-R

Device Problem Deflation Problem (1149)

Patient Problem Tissue Damage (2104)

Event Date 02/09/2017

Event Type  Injury  

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 (b)(4).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

It was reported that the seat section of the bed was deflated and the patient developed pressure ulcer.After a reset with the cpr function, the bed worked fine again.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for the range of triadyne devices, we have been able to find a low number of reportable complaints with the allegation of skin breakdown, however only one (investigated complaint) relates to patient developing skin breakdown while using the triadyneproventa due to cushion seat section deflation.According to that, this particular complaint appears to be an isolated occurrence.It was reported that after two days from the delivery of triadyne proventa asset, on (b)(6) 2017 the customer called stating that the seat section deflated and the patient developed pressure ulcer.Further information collected from the head nurse were that the patient, weighting about (b)(6) with "severe septic disease and an imminent worsening of his condition with failure of the oxygenation" was placed on the triadyne proventa asset for prone therapy for maximum 24 hours.The oxygenation parameters improved while in prone.During the routine check on (b)(6) 2017, it was noticed that the air cushions in the patient's knee section were not inflating.Since it was not advisable to transfer the patient to another asset at that point, the knee discs and pressure reduction cushions were used as an aid.During the device inspection by arjohuntleigh representative, the patient was temporary placed to supine and two pressure ulcers on right and left knee were identified.The pressure ulcers were assessed as stage 3 (pressure ulcer on right knee measured 8cmx5cm; pressure ulcer on left knee measured 5cmx2cm).Additional information provided by the customer was that the patient was multimorbid with high level of catecholamine, which possibly may create side effects such as skin breakdowns vulnerability.After troubleshooting performed by a technician, the device started working as intended.It was indicated that the valve motor malfunctioned, was not opened.The complaint regarding seat section deflation was confirmed.If valve motors are not opening, there is no air flow to the particular section of the mattress.In order to correct that situation cpr handle is applied for about 90 seconds to fully open all valves and deflate the cushion.When completed, the cushions may be inflated to the desired level.Please note, that prior to patient placement, the valve malfunction would be noticed during qc check in a service center while using instaflate function or by the user prior to patient transfer onto the bed when the instaflate feature would be engaged.The device passed the manufacturer's requirements as per qc prior to placement at a customer side.The pressure sensors, instaflate, pulsation functions were checked and no fault was found.No failure was found during patient transfer onto the device either, therefore taking that into consideration, it can be deemed that the valve malfunction was related to the mechanical wear of the part.It was determined that the failure of valve motor alone would not be a contributory factor to the patient outcome.Multiple factors would need to occur in order to lead to the pressure injury.User manual in sections 'risk and precautions' and 'safety information' recommends to monitor skin condition regularly and consider adjunct or alternative therapies for high acuity patients.It is recommended to check the skin pressure point at least every two hours.The document indicates the risk associated with proning, such as skin breakdown and/or pressure necrosis.The "caregiver should make sure to discuss safety information, risk and precautions with patient (or patient's legal guardians) and patient's family".In the complaint at hand, despite of the cushion failure, it was decided not to remove the patient from the device since the patient oxygen level improved while using the triadyne proventa and transferring the patient to the other device might not have been beneficial.Taking the above into account, it has been possible to indicate some factors which might influence patients outcome, such as pre-existing health state, vulnerability to skin breakdown due to the extreme compromised condition, keeping the defective device in use, not following recommendation given in user manual, risk of skin breakdown generally associated with proning therapy.In summary, arjohuntleigh device failed to meet its specification, it played role in the incident as it was used for the patient treatment and therefore contributed to the outcome of the event.Please note, that we report this event due to the patient outcome not due to the failure of valve motor.

• Brand Name: TRIADYNEPROVENTA
• Type of Device: BED, PATIENT ROTATION, POWERED
• 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 ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL ; 698 282 46
• MDR Report Key: 6394756
• MDR Text Key: 69646540
• Report Number: 3007420694-2017-00057
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

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: 308900-CD-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• 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): Other
• Patient Weight: 145