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

Model Number 649STD

Device Problem Sparking (2595)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device inspection conducted at the arjo service center revealed that the power cord was damaged.The sparks could be the result of connecting the damaged power cord to the power source.It is unknown how the power cord was damaged and whether the power cord was securely placed in the cable management flaps by the customer staff who installed the device.According to the nimbus 4 instruction for use (ifu, 649933en_09), arjo recommends ¿make sure that the mains power cable (¿) are clear of moving bed mechanisms or other possible entrapment areas.The mains power cable of this pump is designed to allow movement of the bed, and should be fitted into the cable management flaps along the sides of the mattress, as described in this manual.¿ according to ifu, chapter: routine maintenance: ¿check all electrical connections and the mains power cable for signs of wear or damage.¿ to sum up, the integrity of the cord insulation must first be compromised, before damaging the cable resulting in sparking.The power cord was found to be damaged and from that perspective, the device did not meet performance specifications.There was no indication that any patient was involved when the issue occurred.No injury was reported.The complaint was assessed as reportable due to allegation about the sparks.

Event Description

The nimbus 4 pump was returned to arjo with an indication that the device service is requested because the sparks were observed when the device was being connected to the power source.There was no indication that any patient was involved when the issue occurred.No injury was claimed.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17993746
• MDR Text Key: 326360247
• Report Number: 3005619970-2023-00026
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784412
• UDI-Public: (01)05055982784412(21)2200054486
• 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: Other
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 649STD
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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