MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Deflation Problem (1149)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 06/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

It was reported by patient's daughter that her father was laying on a deflated mattress for unknown time.A patient was admitted to the hospital on (b)(6) 2018.On (b)(6) 2018 it was noticed that the patient was sinking in the middle of the bed.An arjo representative repaired a leaking cell.Later the same day it was noticed that the mattress required another repair.Patient was transferred to another bed.The mattress returned to arjo service center, where two additional cells were replaced.It was reported that the patient was subjected to additional discomfort and pain.

Manufacturer Narrative

This follow-up report is to inform you about progress made thus far.There was no defect found within the pump, according to an arjo technician an alarm was working properly.This system is equipped with an alarm which is activated when the pump detects low pressure within the mattress alerting a caregiver to take an appropriate actions.The patient's daughter stated that it is unknown how long her father was laying on the deflated mattress.It is estimated that the patient was not transfer to the other mattress immediately when the fault was detected by could have been laying on the faulty mattress approximately 4 -5 hours.Additional information will be provided following the conclusion of the investigation.

• Brand Name: NIMBUS 3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• MDR Report Key: 7726299
• MDR Text Key: 115370236
• Report Number: 3007420694-2018-00145
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2018
• Distributor Facility Aware Date: 06/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2018
• Initial Date Manufacturer Received: 06/30/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 06/30/2018
• Supplement Dates FDA Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR