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

Model Number AL14110-US

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted.Additional information will be provided upon conclusion of the investigation.

Event Description

Customer reported that the door would not stay up and the drain would not open.A technician who performed an evaluation found that the door pivot bolt had loosened up and the adjusting screw on the drain plug was missing.After a repair the unit was operating per manufacturers specifications.There was no injury in a result of this incident.

Manufacturer Narrative

An investigation has been carried out and the conclusions are following.Parker bath is intended for assisted bathing and showering of adult residents in care facilities.It is equipped with a full-length side opening for easy access of mobile patients.The 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.A loose screw from the door hinge was the reason for the door not holding its position.Part 6131030 is a screw that fixes a gas strut and a bath door.When it became loose there is not enough resistance for the gas strut to hold the door at different points of opening and the door will slowly lower.A customer reported also that a drain would not open.The reason for this complaint was a missing adjusting screw on a drain plug.This issue however has no impact on the door which would not stay in raised position.Before the incident, the service has been performed on this device by arjohuntleigh technician.According to arjohuntleigh technician part, the screw in question was checked also.After tightening up the bolt and replacing the drain plug the device was confirmed by an arjohuntleigh technician as fully functional.It is unknown why the screw from door hinge became loose and why the adjusting screw on a drain plug was missing.But according to the technician, the customer is dealing with kids with disabilities who are curious and are rough with the equipment.Thus, it is possible that the screw became loose because the door was pushed/pulled inside and outside of the tub during locking and unlocking procedure - swinging the door outside of its original track.This, however, cannot be confirmed with certainty.Instructions for use, which is delivered with each device (ifu, document number 04.Al.01_3us.Ca dated on may 2011) provides preventive maintenance schedule for parker.Based on that door shall be checked every week.The inspection involves checking if door opens and closes properly, "door should not drop by itself during closing".If any malfunction would be noticed during the check, the qualified personnel service needs to be called for repair.The device cannot be used till the repair is completed.It is worth noting that even if screw form hinge door is loose, this is immediately noticed before giving a bath to a resident and the bath shall be excluded from use until it is repaired minimizing any hazardous situation.The customer staff noticed that the door would not hold its position before using it with a patient, but did not take the bath out of use, therefore creating potentially hazardous situation.A root cause cannot be defined with certainty.However, the caregivers found door not working properly before using it with a patient, and despite this continued to use the device.A complaint history records revealed that there were other similar cases, which refer to the door adjustment or broken screw and one from april 2016 which reported drain that would not open due to broken cable.From that perspective and taking into account residents profile it might be suggested that the equipment might have been used incorrectly.Looking at the incident scenario it has been established that the parker bath was being used for patient hygiene at the time of the event, the device failed to meet its specification as a screw from hinge door became loose, and this caused the door not staying in its position.This malfunction on its own does not constitute basis for complaint to be reportable, but additional factor such as keeping the defective device in use might have potentially lead to patient or caregiver injury.For this reason we have decided to report this event.

• Brand Name: PARKER BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 , SW; SW 24121, SW
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 , SW; SW 24121, SW
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 6766985
• MDR Text Key: 82999230
• Report Number: 3007420694-2017-00169
• 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,Followup
• Report Date: 09/04/2017

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 Caregivers
• Device Model Number: AL14110-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2017
• Distributor Facility Aware Date: 07/07/2017
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 09/04/2017
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2011
• 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