MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB TRINOVA

Device Problem Loss of Power (1475)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).It was reported to arjohuntleigh a pt has had some problems with the trinova mattress system causing the mattress to become flat resulting into the pt laying on the metal bars from the bed frame for 6 hours.Skin damage was reported as a result of the event, to be more precise: red and sore marks to his back.The pt was not hospitalized and no treatment was necessary to be applied, to pt recovered after restarting correct use of the mattress system.Based on the eval of this info by the arjohuntleigh clinical expert the pt outcome does not meet the definition of a serious injury.Nevertheless we determined this event to be reportable based on cautious approach towards potential for harm.An arjohuntleigh representative visited the customer to document comprehensive info about the circumstances of the event.The involved pt was a (b)(6) male, the device was used in a private residence setting.During use the trinova mattress system lost mains power and the mattress deflated under the pt, the pump communicated the failure by raising its audible alarm.The pt was left on the deflated mattress for approximately six hours.During that time (b)(6) (the pt's carer) wanted to call 24 hours help line for assistance, however she was unable to call a rental support technician (in primary care trust) because she was informed her contract only allows a call out until 21.00 hrs.Six hours later the pt's carer by chance disturbed the mains lead again, the mains power was restored and the mattress inflated.At that time she realized that the fault was with a damaged mains lead causing intermittent function.On inspecting and testing the pump arjohuntleigh service technician could confirm that the mains lead as damaged - it showed signs of having been pinched (which could come from a bed wheel moving over a cable or other entrapment by bed moving mechanisms) and a plug grommet being defective.During the device inspection it was found that the compressor was noisy, vibrating loudly however was it meeting the required working pressure and flows.The device was repaired by replacement of the mains lead and some other wear parts that are not related to the cause of the event here.It was tested afterwards with positive results.The pat test was also conducted.Moreover from additional observation it would appear that the pt's carer did not move the mains lead out of the way or raise it off the ground, so when bed was moved it could run over or pull the mains lead, hence causing damage which resulted in loss of power.Furthermore in a scenario of power fail the device is equipped with the transport mode which when activated enable to maintain the air in cells for approximately 24 hours.Unfortunately the pt's carer was unaware of this feature on the device.In conclusion the root cause of the mattress deflation was damage of the mains lead that stopped air delivery to mattress causing it to deflate.From the info collected this happened due to inadequate controls by the user for safeguarding the mains cable during use and entrapment by moving bed mechanisms.In summary, the device failed to meet its specification and was being used with a pt for treatment while the event occurred.Given the circumstances and the fact that this incident appears to be an isolated one, we shall continue to monitor for any further events of this nature but do not propose any further action at this time.

• Brand Name: TRINOVA
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall; houghton regis, bedfordshire TX L U5 5; UK TX LU5 5X
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall business; houghton regis, bedfordshire TX L U5 5; UK TX LU5 5X
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4964030
• MDR Text Key: 6640390
• Report Number: 3007420694-2015-00143
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Remedial Action: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1