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

Model Number AP33212-US

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is on-going and additional information will be provided within the next report.

Event Description

Arjo was notified about an event with involvement of system 2000 bath.It was reported that during disinfection of the device the disinfectant handle snapped at fitting and user face was sprayed with diluted disinfectant.The eye wash station was used and follow up with a doctor.The user did not sustain any injury.

Manufacturer Narrative

The arjo representative was informed about the event involving the system 2000 bath tube.It was indicated that during cleaning the bathtub, the disinfectant has sprayed into the caregiver's face.The eyes were flushed with water and the caregiver visited the doctor.No injury was sustained.System 2000 bathing equipment is intended for therapeutic bathing and showering hospital or care facility residents under the supervision of trained skilled nursing staff in accordance with the instructions outlined in the instructions for use (ifu).The arjo disinfectant cleanser iv is intended to be used with medical devices.Please note that system 2000 instructions for use includes the following information: "warning: always use protective gloves and protective eye wear when dealing with concentrated disinfectant.Avoid getting it on your skin or in your eyes.If contact occurs, rinse with copious amounts of water.If skin or eyes become irritated, consult a physician.Carefully follow the instructions on the arjoclean." "the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instruction." in this particular complaint, the involved caregiver was not wearing protective equipment when the event occurred.Moreover, it needs to be emphasized, the device was in use for over 16 years.This product expected operational life has been exceeded about 6 years.Despite that, the device was still in use.From our evaluation we consider this event being the result of handling cleaning and disinfecting agent not according to product labeling (the user was not wearing personal protective equipment at the time of event occurrence).The received information and our evaluation as described above are showing that if instructions concerning product using were followed in accordance with the labeling, there would be no patient or caregiver at risk.In summary, the device was not up to the manufacturer's specification during the event occurrence -the disinfection handle was cracked.The bath tub was not used for patient hygiene at the time of the incident, but it was prepared for use and in that way, it played a role in this event.This complaint was decided to be reported to regulatory authorities due to malfunction occurrence which could result in an injury occurrence as the caregiver's face was sprayed with diluted disinfectant liquid.

• 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: 9160624
• MDR Text Key: 199117193
• Report Number: 3007420694-2019-00160
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AP33212-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other