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

Model Number AL27010-US

Device Problem Device Fell (4014)

Patient Problem Skin Tears (2516)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The involved device was evaluated by the arjo technician.Upon the inspection it was found that an air jet cap was missing on the upper right on the back area.The customer facility representative was not able to determine how the air jet cap fell off.The customer covered the air jet outlet with tape and did not remove the device from usage.Other functions of the bath were working according to the manufacturer's specification.The involved bath was under the arjo service contract at the time of event.According to the received information the last preventive maintenance was carried out on 10/12/2018.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 parker instructions for use (ifu).Please note that according to instructions for use delivered with the device (04.Al.01_7 dated on june 2012), 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." it should be underlined that requirements related to air jets are also provided in ifu section for qualified personnel and within the parker maintenance and repair manual (m&rm; 09.Al.03_4en dated on november 2017).According to these documents, replacement of air jet caps after every 3 years of usage is recommended.Therefore all air jet caps should have been replaced at least one time within this product's usage period.Based on the collected information this requirement was probably not fulfilled.It should be taken into account that according to provided description of event the customer facility representative was not able to determine how the air jet cap fell off and the faulty part was also not kept for inspection.The review of reportable events with the involvement of the parker bath in last 5 years, revealed one similar incident, where a patient sustained an injury due to missing or fell off cap of the air jet.In summary, according to the gathered information, the air jet cap fell off, so the device was not up to the manufacturer's specification at the time of event.The bathtub was used for patient hygiene when the malfunction occurred and in that way it played a role in this event.This complaint was decided to be reported to the competent authority in abundance of caution as the injury occurred.

Event Description

Arjo was notified about an event with the involvement of the parker bath.It was reported that the resident was taking a bath, when an air jet cap (ps1463) fell off and scratched the resident back.According to the received information first aid was administered and bandages were applied on the injured area.The customer covered the air jet outlet with tape and bathtub was used further by the customer despite that malfunction.

• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 8451091
• MDR Text Key: 139806587
• Report Number: 3007420694-2019-00054
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2019

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: AL27010-US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2019
• Distributor Facility Aware Date: 02/27/2019
• Device Age: 5 YR
• Date Report to Manufacturer: 03/26/2019
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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
• Patient Age: 54 YR
• Patient Weight: 46