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

Model Number 649020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 11/26/2021

Event Type  malfunction  

Event Description

The patient fell from the nimbus 4 mattress and non-arjo bed frame.The skin tear on the patient¿s finger was reported as outcome of this event.No medical intervention was needed.

Manufacturer Narrative

Process of gathering and analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

The process of gathering of information is still ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Arjo was informed about an event involving a nimbus 4 system.The 86 years old men fell from the nimbus 4 mattress (arjo product) and non-arjo bed frame.The skin tear on the resident¿s finger was reported as an outcome of this event.No medical intervention was needed.Following information provided by the facility, the fall was unwitnessed by the facility staff.The resident was found on the floor.The bed safety side rails were in the lower position at that time.Usually, the resident¿s wife¿s bed is placed next to the resident¿s bed, but at time of the event it was out of place.The brakes in wife¿s bed were not applied.According to nimbus 4 instruction for use (649933en) "whilst the patient is unattended, the decision to use safety sides should be based on clinical assessment and in line with local policy." the nimbus system was inspected and no malfunction was found.Because the fall was unwitnessed the direct root cause could not be determined.Arjo nimbus system was used for a resident treatment when the event occurred and from that perspective, it played a role in the event.No malfunction was detected during the device evaluation.The complaint was assessed as reportable due to allegation of patient fall, which may lead to serious health consequences.

• 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: 13058422
• MDR Text Key: 289685610
• Report Number: 3005619970-2021-00025
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982788748
• UDI-Public: (01)05055982788748(11)170914
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 649020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Date Device Manufactured: 09/14/2017
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 64 KG