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

Model Number 649010

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

It was claimed by the ward manager that a member of staff suffered an electric shock from a mechanically damage nimbus 4 pump power cord.The caregiver went to the emergency room but no medical intervention was needed.No injury occurred.

Manufacturer Narrative

It was claimed by the ward manager that a member of staff suffered an electric shock from a mechanically damage nimbus 4 pump power cord.The caregiver went to the emergency room but no medical intervention was needed.No injury occurred.The technician who inspected the device and contacted the customer established that the power cord was wrapped between the bed¿s part and it was broken in two pieces exposing the internal wires.The member of staff touched the internal wires and suffered the electric shock.In the investigated case, the cable was positioned without the use of the cable management flaps by the customer staff who installed the device.According to the nimbus 4 instruction for use (649933en_07), 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.¿ the investigation revealed that the lack of use the cable management flaps contributed to the power cord damage between the bed¿s parts.The power cord was found to be damaged and from that perspective, the device did not meet performance specifications.No patient was involved when the claimed issue occurred.The complaint was assessed as reportable due to the electric shock suffered by the member of customer staff.

• 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: 15733844
• MDR Text Key: 307164567
• Report Number: 3005619970-2022-00027
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982788687
• UDI-Public: (01)05055982788687(11)200504
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 649010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2020
• 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