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

Model Number AR52101-EU

Device Problems Unintended System Motion (1430); Physical Resistance/Sticking (4012)

Patient Problem Pain (1994)

Event Date 06/28/2019

Event Type  Injury  

Event Description

Arjo was informed about an event with the involvement of system 2000 bathtub.It was reported that when the caregiver tried to lower the bath to the lowest positon, suddenly the bath stop functioning.The caregiver was not able to activate the bath function once again by pushing the lowering button on the control panel.After few seconds the bathtub lowered unintentionally about 30 cm to the lowest position with noise.As a consequence of the event the patient sustained back pain.

• 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: 8810868
• MDR Text Key: 151701704
• Report Number: 1419652-2019-00184
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AR52101-EU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2019
• Distributor Facility Aware Date: 07/01/2019
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 60