MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AR32201-EU

Device Problem Failure to Disinfect (1175)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 09/19/2021

Event Type  Injury  

Event Description

Arjo was notified about an event with involvement of the system 2000 bath.It was reported that the patient (child) was taking a bath and a few minutes after had a respiratory distress.Emergency service was called to check the patient, they gave him a bronchodilator.It was indicated that arjo clean set up was not correct so the product concentration was too high and the tub was not rinse correctly.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• MDR Report Key: 12545680
• MDR Text Key: 273737124
• Report Number: 1419652-2021-00036
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: AR32201-EU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Distributor Facility Aware Date: 09/20/2021
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization