MAUDE Adverse Event Report: PARKER PARKER MADISON; BATH, HYDRO-MASSAGE

Model Number 530

Device Problem Material Twisted/Bent (2981)

Patient Problem Shock (2072)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The bathtub in question was evaluated by the arjo technician.According to the results of inspection, the support legs on the stretcher support frame were bent.This caused the stretcher legs to catch whilst the bath was being lowered.In consequence this can led them to become detached from the main supports which are attached to the floor.The bath was found to be in poor overall condition due to its age and fact that it has not been serviced for the last 10 years.The customer facility representative stated that similar malfunction (bent stretcher frame) occurred 3 times in the past year, but no indication of any event occurrence was provided.This device is no more manufactured and the parts are not available, so the customer was informed that the bath was not safe to be used.The investigation is on-going and additional information will be provided within the next report.

Event Description

It was reported that whilst the resident was being removed from the tap end of the stretcher, the frame collapsed and the resident slid down the stretcher bathing platform.The resident was prevented from hitting the floor by the caregiver catching the resident.No injuries were reported.The resident was shocked, but it did not require any treatment.

Manufacturer Narrative

It was reported that whilst the resident was being removed from the tap end of the parker madison bath stretcher, the frame collapsed and the resident slid down the stretcher bathing platform.The resident was prevented from hitting the floor by the caregiver catching the resident.No injuries were reported.The resident was shocked, but it did not require any treatment.The device was taken out of use and evaluated by the arjo qualified personnel.According to the results of inspection, the support legs on the stretcher support frame were bent.This caused the stretcher legs to catch whilst the bath was being lowered.In consequence this can led them to become detached from the main supports which are attached to the floor.The bath was found to be in poor overall condition due to its age and fact that it has not been serviced for the last 10 years.The customer facility representative stated that similar malfunction (bent stretcher frame) occurred 3 times in the past year, but no indication of any event occurrence was provided.This device is no more manufactured and the parts are not available.During visit at the customer site after becoming aware of the stretcher failure, arjo representative informed the customer representative that the bath was not safe to be used.The bathing table was an optional addition to the elevating parker madison bath.With the bath in the low position, the table is placed into its location points, where it is level with the bath rim.This allows for simple access by the bather from a standing position, wheelchair, or with the use of a sling hoist.When full, the bath is raised around the bather giving them deep immersion whilst bringing the bath to a comfortable working height for the caregiver.The bather does not move during this process.On completion of the bathing cycle the bath is lowered with the bather remaining on the bathing table.According to the gathered information the claimed bathtub was maintained internally by the customer facility and it has not been serviced by the qualified personnel for at least 10 years (last service in 2009).Please note that manual for parker madison bathtub (issue 2 dated on august 1997 - the earliest available version) includes a requirement regarding the annual maintenance comprising of a full service and safety check, which should be performed by the trained manufacturer service engineers.The review of reportable events with the involvement of the parker madison bath in last 5 years, did not reveal any similar incident.In summary, according to the gathered information, the stretcher frame bent during use, 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 competent authorities due to the customer allegation that the stretcher frame collapsed during transfer and the resident slid down the stretcher bathing platform, which could have resulted in fall.

• Brand Name: PARKER MADISON
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): PARKER; queensway, stem lane; new milton, hampshire BH25 5NN; UK BH25 5NN
• MDR Report Key: 8513519
• MDR Text Key: 141899298
• Report Number: 3007420694-2019-00065
• 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: 05/13/2019

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: 530
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2019
• Distributor Facility Aware Date: 03/20/2019
• Device Age: 25 YR
• Event Location: Other
• Date Report to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 64