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

Model Number AL14110-CA

Device Problem Device Fell (4014)

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

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number 9611530.Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo received a customer complaint for a parker bath.During a service visit at the customer site an arjo technician found that a parker bath's door was not staying up but was falling due to the failure of the gas strut.According to additional information provided by the arjo technician the door did fall and hit a caregiver on the back.No injuries or health consequences were reported.

Manufacturer Narrative

Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Arjo received a customer complaint for a parker bath.During a service visit at the customer site an arjo technician found that a parker bath's door was not staying up but was falling due to the failure of the gas strut.According to additional information provided by the arjo technician the door did fall and hit a caregiver on the back.No injuries or health consequences were reported.The device inspection performed by an arjo service technician revealed that the gas strut had become disconnected from the locking cap.The arjo technician screwed the gas strut back into the locking cap and re-secured it to the bath.The bath was functionally tested and was working properly after the repair.The parker (420) bath's door can be opened by pulling the lever down and lifting the door up.The gas spring is adjusted to facilitate door opening and to keep the balance of the door in raised position, to avoid door falling.Based on the information received the gas strut was found disconnected from the locking cap, causing the bath door to fall freely.The circumstances of the gas strut disconnection are unknown.If the gas strut is defective, the door will not stay in position up.This defect will be noticeable during daily use.The operating and product care instructions for the parker bath (04.Al.00_4) reminds the customer to check the operation of the door on a weekly basis to detect any faults related to this assembly.Unintentional closing of the door and lack of resistance are symptoms noticeable when checking the device.Based on the very limited information received and the unknown circumstances of the gas strut malfunction, it was not possible to determine the exact cause of the failure.In summary, the device was not up to the manufacturer¿s specification due to faulty door part (gas strut).It is not known whether this bathtub was in use with a patient when the gas strut failed.This complaint was decided to be reported to the regulatory authorities due to gas strut malfunction leading to bath¿s door falling on the caregiver's back.No injury was reported.

• Brand Name: PARKER BATH
• 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: 17331337
• MDR Text Key: 319398503
• Report Number: 3007420694-2023-00169
• Device Sequence Number: 1
• Product Code: ILJ
• 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,Followup
• Report Date: 09/14/2023

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: AL14110-CA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 06/19/2023; 06/19/2023
• Supplement Dates FDA Received: 08/16/2023; 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2009
• 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