MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. PARKER BATH; ILM

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

It was initialy reported to arjohunteigh representative that: "door is heavy to close and tub leaking from drain.Found door strut worn not supporting door fully.Replaced door strut.No patient involved, no risk or injury reported.".

Manufacturer Narrative

An investigation was carried out into this complaint.When reviewing similar reportable events for parker bath we have found a low number of other similar cases - gas strut was unable to support the door.There is no information if the device was being used for the patient therapy.The gas strut was unable to support the door - in that way it contributed to the event.It is not clear when the malfunction has been found due to fact that caregivers were from a 3rd party company.It is unknown which caregiver discovered this problem and in what circumstances.Information gathered during our investigation confirms that the latest replacement of the gas strut on the device at hand has been performed on (b)(6) 2014.Unfortunately the faulty part is not available for return for further examination.The age of the device is significant when this kind of the malfunction occurs.Looking at the date of the production of this device, it was manufactured in 2001 and has already passed its operational lifetime as identified in the device labelling a 5 years ago.All devices are equipped with instruction for use which clearly inform that: "always keep fingers clear of the door when closing"."the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventive maintenance as specified in this manual".Due to the nature of this incident we are reporting this event to competent authorities in the abundance of caution - even though no injury occurred, there was a possibility of harm.From all of above information we could not determine the exact root cause of the failure.It cannot be established if the bath was being used for patient handling but it appears that the device was not according to specification when the event occurred.It appears to have played a role in the event due to having been long outside of its intended lifetime - which is considered to be use error.Despite our best efforts the part was not available for return, we could not test it and establish exact root cause of the problem.Arjohuntleigh suggests to remind the facility that the device passed its operational lifetime and it should be replaced.This is to be communicated to the customer.

• Brand Name: PARKER BATH
• Type of Device: ILM
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio,, TX 78247 ; 2103170412
• MDR Report Key: 5833041
• MDR Text Key: 50818288
• Report Number: 3007420694-2016-00160
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/31/2016,07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 08/31/2016
• Distributor Facility Aware Date: 07/06/2016
• Device Age: 15 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/29/2016
• Date Manufacturer Received: 07/06/2016
• Date Device Manufactured: 02/26/2016
• 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