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

Model Number 649015

Device Problems Deflation Problem (1149); Sparking (2595)

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

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

The arjo service technician reported that the pump¿s cable pinching resulted in damage of the mains power insulation and exposed internal wires.Due to that, there was no power to the pump and mattress started to lose air.The power cord damage also contributed to the sparks emission.The photographic evidence provided confirmed cable damage.The arjo employee reported also that the cable was not positioned correctly.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.¿ to conclude, upon the conducted investigation, it was determined that the cable management system might not be used.It caused that the power cord was damaged when pinched most likely between moving parts of the bed.The damage of the power cable was a contributing factor to the observed mattress deflation and sparks emission.The power cord was found to be damaged and from that perspective, the device did not meet performance specifications.The pump was in use by a patient when the issue occurred.No injury was reported.The complaint was assessed as reportable due to allegation about the sparks.

Event Description

The customer¿s employee informed arjo that the nimbus 4 pump¿s power cord damage caused the mattress to deflate and the residual current circuit breaker to blow.The staff claimed also sparks from the damaged cable.The system was in use by a patient at the time of event.No injury was reported.The claimed device was repaired.

• 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: 18290002
• MDR Text Key: 330831373
• Report Number: 3005619970-2023-00029
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/08/2023

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: 649015
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 83 YR
• Patient Sex: Female