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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 4; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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ARJO (SUZHOU) CO., LTD. NIMBUS 4; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number 649STD
Device Problem Deflation Problem (1149)
Patient Problem Pressure Sores (2326)
Event Date 12/12/2023
Event Type  Injury  
Event Description
Arjo became aware of the event involving the nimbus 4 pump and the nimbus professional mattress.The customer alleged that when the patient was lying on his side one of the mattress cells deflated and the patient was feeling the bed frame.Due to that the patient sustained serious pressure injury.The customer also informed that the sinking of the patient was not visible and the pump was not alarming.The problem became apparent when the patient was placed back in the supine position.The system was returned to arjo for evaluation.
 
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Brand Name
NIMBUS 4
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
ARJO (SUZHOU) CO., LTD.
no. 158 fangzhou road, sip
suzhou, jiangsu 21502 4
CH  215024
MDR Report Key18474370
MDR Text Key332429001
Report Number1419652-2024-00003
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/09/2024
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? Yes
Device Operator Health Professional
Device Model Number649STD
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/09/2024
Distributor Facility Aware Date12/12/2023
Event Location Hospital
Date Report to Manufacturer01/09/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/09/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight130 KG
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