MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR52311EU0110

Device Problems Device Maintenance Issue (1379); Chemical Spillage (2894); Device Operational Issue (2914)

Patient Problems Irritation (1941); Sore Throat (2396)

Event Date 01/09/2014

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh representative that a disinfectant came into the bath water during usage the hydromassage.From the information received both caregiver and resident was red in the throat, and irritation in throat occurred form inhaling the disinfectant.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3764905
• MDR Text Key: 4549626
• Report Number: 1419652-2014-00022
• Device Sequence Number: 1
• Product Code: ILM
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AR52311EU0110
• 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: 01/27/2014
• Distributor Facility Aware Date: 01/09/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Weight: 70