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

Model Number UNKNOWN

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/20/2022

Event Type  Injury  

Event Description

Arjo was notified about an event with involvement of the system 2000 bath.It was reported that a resident was showered with the wrong shower handle which means that the patient was showered with arjo clean disinfectant.It was indicated that the resident sustained burns and had to go to the hospital for 10 days to be treated.

Manufacturer Narrative

The device was evaluated by an arjo representative.It was indicated that the bath is not equipped with the original arjo shower handles, but with normal shower handles that can be purchased anywhere in the market.Collection of additional information is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

Arjo was not able to confirm involvement of arjo device for the event reported.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Arjo was notified about an event where it was reported that a resident was showered with disinfectant.It was indicated that the resident sustained burns and had to go to the hospital for 10 days to be treated.

Manufacturer Narrative

Collection of additional information is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

An arjo technician visited the customer facility to performed a scheduled service on arjo product (different from the one investigated in this report).During his visit a person from the facility talked about a patient who had returned from a 10-day hospital stay due to burns sustained after showering with disinfectant.The arjo technician was trying to receive more details about the event and whether arjo device could be involved in the event, but the person was reluctant to share more information.While wandering around the facility the arjo technician noticed that arjo baths in this facility have shower handles which were not arjo parts and that all disinfection handles had yellow tapes on disinfection shower handles to differentiate them from shower handles used for showering.Photographic evidence of random arjo bath and arjo shower panel provided showed that these dymo tapes have no signs of damages, which suggests that these stickers could be added recently.Based on his observation he assumed that arjo bath could be involved in the event but this assumption was not confirmed by the customer.The arjo technician offered possibility of shower handles replacement.Despite our effort, the details of the event and whether an arjo device could be involved in the event have not been shared with arjo.The customer did not say that arjo device was involved in the event.Arjo's shower and disinfection handles are easy to distinguish for users.The shower handles are gray in color, while the disinfection handles are yellow in color with an exclamation mark on the side.The disinfection handle is placed inside the bath panel while one or two gray shower handles (depending on the order) are placed outside the bath panel and hang on the side of the bath panel.Arjo control panel bath has separate buttons for showering and separate button for disinfection.We did not find any other complaints where the customer would use the disinfection handle instead of the shower handle.Therefore, we believe that the event, overheard by the arjo technician, is unlikely to occur with an arjo device.To sum up, we were not able to verify whether arjo device was being used for patient¿s showering when the event occurred.Therefore, we cannot established that arjo device contributed to the event.Based on very limited information received the cause of the event cannot be established.This complaint was initially decided to be reported the competent authorities, in abundance of caution, due to serious injury reported and due to initial assumption made by the arjo technician, which was not confirmed by the customer, about potential involvement of an arjo bath in the event.However, after analysing all the information gathered, our final conclusion is that there was no connection between the arjo device and the patient¿s injury and it is unlikely that an arjo device contributed to the event.Therefore, we believed that this complaint does not meet the criteria for adverse event reporting since arjo device was not confirmed to be involved in the event.

• Brand Name: UNKNOWN
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13708975
• MDR Text Key: 286845297
• Report Number: 3007420694-2022-00037
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2022

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: Other
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 02/28/2022; 02/28/2022; 02/28/2022
• Supplement Dates FDA Received: 04/07/2022; 04/29/2022; 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Male