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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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ARJO (SUZHOU) CO., LTD. NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skull Fracture (2077)
Event Date 03/17/2021
Event Type  Injury  
Event Description
Arjo was informed about an event involving the enterprise 5000 bed frame and nimbus system (mattress and pump) which were used on a post-natal ward.Following the information gathered, a baby lying on the bed with mother fell out of the bed and sustained a cracked skull.The baby fall was unwitnessed by the facility staff but the mother informed that she fell asleep whilst the baby was in her arms.The safety side rails were in the lowered position at that time.As two arjo devices were involved in the adverse event (nimbus system and enterprise 5000 bed frame), an additional report for the enterprise 5000 bed frame was submitted under number (b)(4).
 
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Brand Name
NIMBUS 3 / DFS3
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 Key11647641
MDR Text Key248387740
Report Number1419652-2021-00010
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 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2021
Distributor Facility Aware Date03/17/2021
Event Location Hospital
Date Report to Manufacturer04/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
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