MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AP32801-EU

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

It was initially reported by company representative that smoke was coming from the unit during use: "a client was having a spa bath when a staff member noticed "smouldering and smoke" coming from the bath.It became clear that the spa had caught fire and so the fire brigade was called immediately.The fire crew arrived within 4 minutes and evacuated the facility and contained the fire and de-commissioned the bath.The client was treated by a doctor." reported incident has been clarified in provided incident description form (idf): "carer entered the room and found it was filling with smoke.The staff member calmly helped the client out of the bath.No flames were reported." from the info rec'd no injury occurred to the patient or caregiver.Patient was observed overnight and taken to the doctor next day but no lasting effects.Mfr report #: 9611530-2014-00041.

• 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: 3964795
• MDR Text Key: 4605562
• Report Number: 1419652-2014-00166
• Device Sequence Number: 1
• Product Code: ILM
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AP32801-EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2014
• Distributor Facility Aware Date: 05/26/2014
• Device Age: 9 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 79