MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 152010DAR

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Fungal Infection (2419); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2022

Event Type  Injury  

Event Description

The patient sustained the fungal infection as a result of contact with the allegedly contaminated nimbus 3 mattress.It was claimed that a soiled item of clothing (blood stained underwear) was found by the customer staff under the cells when the mattress cover was opened.The patient stayed at the customer facility until the infection has cleared up.

Manufacturer Narrative

Additional information received from the involved patient allowed to clarified that he had the fungal infection before start of use the arjo mattress (it was pre-existing condition).There was no allegation from the patient that the infection was caused by the items in the mattress.Follow-up report was submitted to correct the information provided.

Event Description

Initially, arjo became aware that the patient developed the fungal infection as a result of contact with an allegedly contaminated nimbus 3 mattress.The customer claimed that a soiled item of clothing (blood stained underwear) was found by the customer staff under the cells when the mattress cover was opened.The patient stayed in the customer facility until returned to recovery.Additional information received from the involved patient allowed to clarified that he had the fungal infection before start of use the arjo mattress (it was pre-existing condition).There was no allegation from the patient that the infection was caused by the items in the mattress.

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 14641285
• MDR Text Key: 293618075
• Report Number: 1419652-2022-00026
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/04/2022
• Distributor Facility Aware Date: 05/27/2022
• Device Age: 9 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male