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

Model Number AL14110-US

Device Problem Device Fell (4014)

Patient Problem Skin Tears (2516)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The involved devices were evaluated by the qualified arjo representative.Based on the results of this inspection, the airjet caps fell off.The investigation is on-going and additional information will be provided within the next report.

Event Description

Arjo was notified about an event with involvement of parker bath.It was reported that a patient got scratched on the back with the top of the tub when getting out of the tub.

Manufacturer Narrative

Arjo was notified about an event with involvement of parker bath.It was reported that a patient got scratched on the back when getting out of the bath.No information regarding need of or applied treatment was made available.The involved device was removed from usage and evaluated by the qualified arjo representative.Based on the results of this inspection, three air jet caps were missing, which created a rough surface in the bath.The new caps were then installed.After that the bath was tested and put back to service.It was unknown, when the caps fell off their intended place.The claimed device was not under the arjo service agreement, but was maintained internally by the customer.Upon the visit at the facility the customer representative was reminded to not use the tub if any caps are missing.The parker bath is subject to wear and tear, and some actions must be performed when specified to ensure that the product remains within its original manufacturing specification.To avoid malfunction resulting in injury, the user should make sure to conduct regular inspections and follow the recommended maintenance schedule provided within the operating and product care instructions (opci/ifu).The involved bath was not under the arjo service agreement at the time of event and it was unknown, when the last annual service was conducted.According to the history of services performed by arjo for this bathtub, 2 of 9 air jet assemblies (including caps) were replaced in september 2016.Please note that according to operating and product care instructions delivered with the device (ifu; 04.Al.00_4 dated on april 2007), user of the bath in question should follow the instructions from the booklet.In connection with a subject of this investigation, the ifu provides preventive maintenance requirements including those related to air jets.In section "care and preventive maintenance" the ifu the preventive maintenance schedule is available, which includes the obligation to visually check all exposed parts (such as air jets) on a weekly basis: "visually check all exposed parts, especially where personal contact is made by either the resident or caregiver.Make sure no cracks or sharp edges have developed that could cause the resident or user injury or that has become unhygienic." it should be underlined that requirements related to air jets are also provided in ifu section for qualified personnel.According to it a replacement of air jet caps after every 3 years of usage is recommended.Based on the collected information it was not possible to confirm that this requirement was fulfilled.It is to be mentioned that the caps in question were missing and therefore not available for further inspection of their condition.Based on the performed analysis it was not possible to determine the exact root cause of event as it was unknown when the caps detached e.G.During the reported event or earlier.It is probable that the preventive maintenance schedule included in ifu was not followed, which could have been the contributing factor for this malfunction.In summary, according to the gathered information, the air jet cap fell off and were missing.The bathtub was used by the customer for patient therapy.The device was not up to the manufacturer's specification at the time of event.This complaint was decided to be reported to regulatory authority due to malfunction occurrence, which contributed to the patient injury.

• 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: 8959127
• MDR Text Key: 199115432
• Report Number: 3007420694-2019-00146
• 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: 10/03/2019

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-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 60