MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/04/2019

Event Type  Death  

Manufacturer Narrative

The investigation is on-going and additional information will be provided in the next report.

Event Description

Arjo was notified about the event with involvement of system 2000 bath.It was reported that a patient died during use of the bathtub.According to the received information the care unit has requested a training.No further information was made available to date.

Manufacturer Narrative

Arjo was notified by french national competent authority (ansm) about the event with involvement of system 2000 (rhapsody) bath.It was reported that a patient died during use of the bathtub.Other information included in the report referred to the request for training.No further details have been provided to date.It should be underlined that arjo was not informed about the incident directly by the customer facility.The first notification was delivered by (b)(6) on (b)(6) 2019, after over two months from the incident occurrence date ((b)(6) 2019).Arjo representative made multiple attempts to contact the customer facility, but the requested information was not provided and the device was not made available for evaluation.Due to the limited data, we were not able to establish a root cause or any connection between the device and the event or the event's outcome.In summary, according to the gathered information the system 2000 bath was used for patient handling at the time of the event.The link between the device and the alleged incident was not established.The device was not available for evaluation, hence no malfunction could have been identified.This event was decided to be reported to regulatory authorities due to allegation of a patient death and claimed involvement of the arjo device in the event.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 9213152
• MDR Text Key: 162984461
• Report Number: 3007420694-2019-00171
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

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?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death