MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 151010

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  Injury  

Event Description

Arjo received allegation from the customer representative about sparks from the pump power cord with damaged insulation.No injury was reported.

Manufacturer Narrative

The pump power cord was mechanically damaged, the insulation was broken.It contributed to occurring the sparks.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Manufacturer Narrative

Arjo received allegation from the customer representative about sparks from the pump power cord with the damaged insulation.No injury was reported.An arjo technician during an on-site visit checked the device and found the pump power cord was mechanically damaged by the bed castors.The insulation was broken exposing the internal copper wires.It contributed to occurring the sparks.According to the nimbus 3 instruction for use (151996) ¿make sure that the mains power cable (.) are clear of moving bed mechanisms or other possible entrapment areas.Where cable management flaps are provided along the sides of mattress, these should be used to cover the mains power cable.¿ the power cord was found to be damaged and from that perspective, the device did not meet performance specification.There was no allegation that any patient was involved.No injury or other medical consequences occurred.The complaint was assessed as reportable due to indication about occurring the sparks from the power cord cable with damaged insulation.

• 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
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 12850470
• MDR Text Key: 282385641
• Report Number: 3005619970-2021-00021
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

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: Other
• Device Model Number: 151010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2011
• 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