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

Model Number	651201DAR
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
Event or Problem Description
A patient was lying on the mattress, when the air cell inflated too hard, causing the patient to roll to one side.The siderails were in raised position, preventing the fall.No injury was sustained.In order to release the air, the customer cut the automatt.
Additional Manufacturer Narrative
The customer alleged that automatt (which is a mattress component) over-inflated.The patient (70 years old female, weight 60kg), who was intubated, was at that time on the mattress.The overinflation allegedly caused the patient to roll to one side.The side rails were in the raised position, allegedly preventing the fall.No injury was sustained.The cause of the automatt overinflation is the incorrect circulation of the air in the automatt sensor pad (mattress base) due to a damaged inner tube.The tpu (thermoplastic polyurethane) tube may break over time due to the extruding force of the silicone tube and the external bending force, causing air accumulation in automatt.The automatt could not be evaluated as the customer cut the automatt in order to release the air.The customer however provided photographic evidence, which shows that one of the grommets membranes was punctured and the other removed from the automatt.The manufacturer decided to perform simulation with the involved product and another automatt to verify the customer¿s allegation.The simulation confirmed that the overinflation of the automatt will not occur with the load on the mattress.This confirms that when the grommet membrane is punctured, air escapes through the punctured membrane, and the mattress can deflate, reducing the risk of the automatt over-inflating when the patient is lying on the mattress.The customer allegation could not be confirmed with the simulation performed, therefore we are unable to ascertain the alleged patient's near-fall to the overinflation.The cause of the rolling to the side is unknown.In summary, the nimbus mattress did not meet its specification since the automatt sensor pad was faulty.The reported issue occurred when allegedly the device was used by the patient.No injury was reported.The complaint was decided to be reportable due to the initial indication of a risk of patient¿s near fall.This however could not be confirmed in the course of the investigation.If additional information is available, this complaint will be re-evaluated accordingly.

• Brand Name: NIMBUS PROFESSIONAL
• Common Device Name: 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: 16759906
• Report Number: 3005619970-2023-00006
• Device Sequence Number: 14192855
• Product Code: FNM
• UDI-Device Identifier: 05055982782210
• UDI-Public: (01)05055982782210(11)150507
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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 Model Number: 651201DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 87752
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG