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

Model Number AL14610-GB

Device Problem Device Fell (4014)

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

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the results of evaluation, the door gas strut was found defective and not holding the bath's door, which caused the door's unintended closing.The investigation is on-going and additional information will be provided in the next report.

Event Description

Arjo was notified about an incident with involvement of the parker bath.It was reported that the customer facility's nurse stated that the door almost fell on her head.No injury occurrence was indicated.

Manufacturer Narrative

Arjo was notified about an incident with involvement of the parker bath.The customer facility's nurse stated that the door almost fell on her head.No injury occurrence was indicated.The customer marked the device faulty and removed from service right after the described malfunction was noticed.According to the results of evaluation, the door gas strut was found defective and not holding the bath's door.There was no visible damage on the part detected, but the functionality was deteriorated.The operating and product care instructions informs the device user that the door gas strut is subjected to wear and it is recommended to be preventively replaced every 3rd year.The opci also provides warnings and actions that can be carried out to avoid the reported situation from occurring: ¿always ensure that the bathers limbs are clear of the door before closing.¿ ¿always keep fingers clear of the door when closing.¿ ¿always ensure that the equipment is handled by trained staff.This model of the parker bath (420) has been discontinued and the claimed unit was manufactured over 13 years before this malfunction occurred.As per the operating and product care instructions: ¿the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in this manual.¿ based on the performed analysis, the root cause was found to be related to normal wear of the component.In summary, the device was not up to the manufacturer¿s specification as the door was falling due to faulty gas strut, which was noticed by the customer facility personnel.This complaint was decided to be reported to the competent authorities in abundance of caution due to gas strut malfunction leading to bath¿s door falling, which according to the customer allegation occurred when the bath was used by the caregiver and the who was almost hit by the door.

• Brand Name: PARKER BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 24121 ; SW 24121
• MDR Report Key: 11336709
• MDR Text Key: 232519134
• Report Number: 3007420694-2021-00023
• 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: 03/16/2021

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: Health Professional
• Device Model Number: AL14610-GB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other