MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB CAIRWAVE / RENAISSANCE; FNM

Model Number 7303

Device Problems Deflation Problem (1149); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Following the information gathered the cairwave mattress went down while the physically disabled patient was lying on it.The pump then was switched on and it started to inflate again but it was pumping the mattress up hard without warning.The review of reportable complaints with cairwave showed that there were no similar events.Therefore, the incident described above seems to be an isolated case at this time.It can be established that the cairwave mattress and pump, which work together as a system, were being used for patient care when the event took place, and as such it appears the system played a role in the event outcome.The cairwave system was inspected and was found to work properly as intended: "the equipment went through decontamination and testing, no faults were found".Therefore, the system was found to have been to specification when the event took a place.Despite on our best efforts, it is difficult to address the root cause of this issue based on very limited details received.We are left to review the information provided from the customer, and compare it to our product knowledge that in part comes from previous complaint investigations.It was reported that the cairwave pump was switched on to inflate the mattress again.Based on this, it is possible that the patient management unit was not switched on before.This could be confirmed by lack of the customer observation regarding lights and alarms presented at that time of the event.Therefore, the use error cannot be ruled out.The cairwave user guide (lft4623) informs the user about setting up the system: "plug the socket of the mains lead into the patient management unit (pmu).The mains switch power socket and fuses are situated on the right hand side of the pmu with fuse rating label alongside.(.) plug the mains lead into a suitable electrical socket and switch on the pmu.The audible alarm will sound and all the lights on the front panel will illuminate for approximately 2 seconds.The unit will then go into fast inflation mode".We determined this event as reportable in abundance of cautions, as initially we received initial allegation that the device caused or contributed to the pressure ulcer worsen.Nevertheless information provided later by the primary carer that in her opinion there was no adverse outcome for the patient, ie the patients condition had not worsened.

Event Description

On (b)(6) 2015 arjohuntleigh received a customer complaint where it was reported that the patient who is physically disabled and at the moment has three pressure sores was lying on the mattress which was going down.It was indicated that they tried the switch on the pump and it started to inflate again, except now it was pumping the mattress up hard without warning.It was suggested that the patient was left in an unacceptable position on the mattress that was not working and that this might have had a detrimental effect on the sores.

• Brand Name: CAIRWAVE / RENAISSANCE
• Type of Device: FNM
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton; houghton regis; bedfordshire, LU5 5 XF; UK LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton; houghton regis; bedfordshire, LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: pamela wright ; 12625 wetmore,; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5288429
• MDR Text Key: 33234240
• Report Number: 3007420694-2015-00228
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/11/2015,11/12/2015

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: Patient Family Member or Friend
• Device Model Number: 7303
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2015
• Distributor Facility Aware Date: 11/12/2015
• Event Location: Home
• Date Report to Manufacturer: 12/11/2015
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/11/2015
• 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