MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 4; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 649STD

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

A copy of customer¿s declaration ref.(b)(4).Including description of an event involving an arjo device (nimbus 4 system: pump model 649std with serial number 2000026450 and the mattress model 650001dar with serial number (b)(4) and non-arjo bed frame (eleganza bed frame) was forwarded to arjo.There was noted that a hemiplegic patient was found on the ground after falling from the bed.No injury occurred, no medical intervention was needed.The customer speculated in the report that the nimbus 4 mattress made difficulties in locking the bed side rails due to its width 89 cm.The nurses allegedly had to force to obtain double locking of them.The customer noted also that they favour the installation of mattresses (type alpha active) with width 80 cm.Based on the above, it has been determined that the mattress did not fit to the bed frame (it was too wide).The customer staff was aware about it as experienced difficulties in double side rail locking.It is unknown why the patient¿s fell from the bed.The involved non-arjo bed frame was quarantine to check the integrity of the rails interlock therefore we may only suspect that the side rail of non-arjo bed frame unexpectedly opened or was left opened.There were no suggestions or statements of nimbus 4 mattress malfunction.In summary, the nimbus 4 system played a role during this event as it was used along with the non-arjo bed frame.No information about nimbus 4 system malfunction was reported.The complaint was assessed as reportable due to allegation of the patient¿s fall, which may lead to serious health consequences.

Event Description

A copy of customer¿s declaration ref.(b)(4).Including description of an event involving an arjo device (nimbus 4 system) and non-arjo bed frame (eleganza bed frame) was forwarded to arjo.There was noted that a hemiplegic patient was found on the ground after falling from the bed.No injury occurred, no medical intervention was needed.

• 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
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14159891
• MDR Text Key: 289664533
• Report Number: 3005619970-2022-00007
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784412
• UDI-Public: (01)05055982784412(11)200523
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/20/2022

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
• Device Model Number: 649STD
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2020
• 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