MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SHOWER CABIN (PRELUDE); BATH, SITZ, NONPOWERED

Model Number BBA1254-04

Device Problem Device Tipped Over (2589)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Event Description

Arjo was informed about the incident involving the prelude shower cabin.It was reported that the device tilted over during use.The patient involved in the incident did not sustain any injury.After the event, the device was evaluated by an arjo representative.The technician's inspection revealed that one of the base corners of the cabin had corroded.

Manufacturer Narrative

Investigation is ongoing.The follow-up will be provided within next report.

Manufacturer Narrative

Arjo was informed about an incident involving the prelude shower cabin.The customer reported that the device tilted over during use due to corrosion of one of the base corners of the cabin.The patient involved in the incident did not sustain any injury.Following the information provided by the service technician, it is unknown when the last maintenance of the device was performed.In march 2022, the shower & disinfection panel which was used with the prelude shower cabin at the customer's site was repaired due to leaks.The shower cabin itself was not checked at that time.According to the information gathered, the prelude shower cabin is not covered by the arjo maintenance contract, unlike the shower & disinfection panel.The prelude shower cabinet "operating and product care instructions" in the "preventive maintenance schedule" section instructs the user: "weekly: examine the cabinet for cracks or other damage (¿) yearly: check all vital parts for corrosion/damage".The device was manufactured in 2001, so it is now almost 21 years old.The "operating and product care instructions" informs that "the useful life of this equipment, unless otherwise stated is ten (10) years (¿)".Based on the above information, the most probable root cause of the reported malfunction is normal wear due to the age of the device.To sum up, the shower cabin prelude tilted over during being used and from that perspective the device did not meet its performance specification.The complaint was decided to be reported to competent authorities due to allegation that the device tilted over during use.No injury was sustained.

• Brand Name: SHOWER CABIN (PRELUDE)
• Type of Device: BATH, SITZ, NONPOWERED
• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14600846
• MDR Text Key: 300914761
• Report Number: 3007420694-2022-00086
• Device Sequence Number: 1
• Product Code: KTC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 06/28/2022

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: Other
• Device Model Number: BBA1254-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2001
• 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): Other