MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH

Model Number 420

Device Problems Crack (1135); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Abrasion (1689); Skin Tears (2516)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative who visited the customer site and inspected the device that after bathing, the resident sustained skin tear."resident was getting out of tub with assistance.As he was sitting down in the wheelchair, his feet came up and hit the bottom of the tub shroud".From the received information abrasions on toes and superficial, skin tear occurred to the resident as a result of this incident.Injury was assessed and treated in house.Device examination included in incident description form (idf) showed that involved tub is in poor condition, with scratches, water marks, numerous improper fixes to the tub.In accordance to arjohuntleigh's representative, maintenance has not been completed properly.Function test showed that tub up/down and tilt functions are intermittently not working.There were found multiple leaks from air jet elbows, drain line is cracked, door seal holds water, but is in need of repair.Shower and tub fill knobs are very difficult to turn off.The examination showed that tub shroud is cracked, torn, and holes have been drilled through in multiple spots for cable ties to hold pipe insulation.All jet caps/need to be replaced (either broken or dirty) and some have been disconnected and a nut and bolt used to prevent water leakage.Door handle is broken, screws missing from back panel, batteries old and causing intermittent tilt/up/down functions.Drain line cracked, cartridges old/worn/ and not turning easily.Door seal improperly installed, jet caps missing, push jet assemblies broken/worn.Out of all liquids.Disinfectant drain hose missing.Additionally, the environment where tub is placed has been examined.There were found lifts stored in tub room - supposed to be removed when bathing.Last maintenance was performed by the customer, however date of it is unknown.Device is serviced in house.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for parker bath, we have found low number of other cases where the resident sustained skin tear after bathing.There is no complaint trend for these kind of events.Please note that arjohuntleigh manufactured about (b)(4) parker baths to date.With the amount of sold devices and with comparison to the daily use of them, the trend observed for complaints with this failure mode is considered to be very low and acceptable.(b)(4).The device was inspected by an arjohuntleigh representative at the customer site and found to be out to the specification - poor device condition with damaged and worn parts.The device was being used for patient handling and in that way contributed to the event.From the information received abrasions on toes and superficial skin tears occurred to the patient as a result of this incident.Received information and provided photos of involved device showed that parker bath was in poor condition, with scratches, water marks, numberous improper fixes to the tub, tub shroud is cracked, torn and tub trim is missing.In accordance to arjohuntleigh representative who examined involved device: "maintenance has not been completed properly".Last maintenance was performed by the customer, however date of it is unknown.From above findings we conclude that this incident was caused by a combination of user error - poor maintenance and not following ifu's recommendations.The received information and our evaluation as described above are showing that if parker's maintenance procedures were followed in accordance to preventive maintenance schedule, there would be no patient or caregiver at risk.

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4309316
• MDR Text Key: 5212285
• Report Number: 3007420694-2014-00112
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/26/2014,10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420
• 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: 11/26/2014
• Distributor Facility Aware Date: 10/27/2014
• Device Age: 11 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/29/2014
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2003
• 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