MAUDE Adverse Event Report: ARJO HOSP. EQUIPMENT AB SYSTEM 2000

Device Problems Device Maintenance Issue (1379); Use of Device Problem (1670); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Pain (1994); Injury (2348)

Event Date 12/12/2013

Event Type  No Answer Provided  

Event Description

Initially it was reported by arjohuntleigh representative that resident slipped under the water.Problem was caused by incorrect use of the product - the nurse accidentally pressed the wrong button (the disinfection button instead of the shower button) while the patient was having a bath and the bath was full.The hydrotherapy suction function turned on and the patient slipped under the water and got quite a fright.The patient tried to stand up but the force of the water pulled her under the water.The caregiver tried to turn off the hydrotherapy by using the button but it would not work.The bath was then turned off at the mains switch.The patient was complaining of a sore ankle.Reference mfr # 9611530-2014-00002.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSP. 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: 3610907
• MDR Text Key: 4170870
• Report Number: 1419652-2014-00008
• Device Sequence Number: 1
• Product Code: ILM
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2013

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2014
• Distributor Facility Aware Date: 12/12/2013
• Device Age: 13 NA
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR