Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Device Problem Deflation Problem (1149)
Patient Problem Pressure Sores (2326)
Event Date 06/01/2023
Event Type  Injury  
Event Description
Arjo became aware of the event involving the nimbus 3 system.The customer alleged that the mattress deflation resulted in the patient¿s stage 4 pressure ulcer.The system was returned to the arjo and evaluated.It revealed 3 small holes in the mattress (in the heel guard, in the short cell and in the torso cell) and the small spilt in the compressor tubing.It caused that the mattress did not reach normal operating pressure.However, the revealed air loss did not cause mattress fully deflation and the low pressure alarm activation.The pump alarm was activated while the cpr was used causing the fully mattress deflation.The system was repaired and returned to the customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NIMBUS 3 / DFS3
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 Key17867493
MDR Text Key324869480
Report Number1419652-2023-00055
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 10/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2023
Is this an Adverse Event Report? Yes
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 FDA10/04/2023
Distributor Facility Aware Date09/07/2023
Event Location Hospital
Date Report to Manufacturer10/04/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight60 KG
-
-