MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH

Model Number AL14110-US

Device Problems Component Falling (1105); Detachment of Device or Device Component (2907); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Bruise/Contusion (1754)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

Reference importer report number: (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for parker bath, we have found a number of cases with a similar fault description- door fell down.We have been able to establish that there is a complaint trend concerning defective fall of door, recorded under brand name: parker bath.Please note that arjohuntleigh manufactured over (b)(4) parker baths to date.With the amount of sold devices and with comparison to the daily use of them in the trend observed for complaints with this failure mode is considered to be low and acceptable.The device was inspected by an arjohuntleigh rep at the customer site and found to be out of specification.The device was being used for patient handling and in that way contributed to the event.Maintenance and repair manual (09.Al.00/1gb from june 2003) informs about general and function check which includes checking door operations as well, and provides also preventative maintenance schedule (pms).In accordance to this pms the customer is obliged to check door lock and operation every week.This same check should be done by qualified personnel every year.It is also necessary that authorized service replace door gas strut every 4 years.Maintenance and repair manual provides also procedure of correct check of the door and repair of gas strut and door stop bolt adjustment.The instructions for use (ifu) are supplied with each device (04.Al.00/4 us, ca from april 2007) and provide info about correct and safe use of the device.It informs how to correctly operate the door and informs about care and maintenance of the device.This instruction (introduced about a year before manufacturing date of complained parker bath) is a new document than above mentioned maintenance and repair manual and includes info about more frequent replacement of the gas strut.In accordance to this ifu qualified personnel is obliged to replace door gas strut every 3rd year.Please note that this device was in use for about 6 years and there should be at least 1 scheduled replace of gas strut, however, from the received info regarding maintenance of this parker bath, it had never been replaced at all.The issue with parker's door falling down and gas strut replacement was investigated.The preliminary defined root cause as documented in is poor maintenance- lack of replacement.In accordance to above we conclude that this incident was caused by user error- lack of maintenance: user didn't follow recommended maintenance procedure as stated in instruction for use.The received info and our eval as described above are showing that if parker's maintenance procedures were followed in accordance to instruction for use or maintenance and repair manual, there would be no patient or caregiver at risk.The issue will be monitored through the arjohuntleigh complaint handling system to closely follow up the need for possible actions.

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3799185
• MDR Text Key: 4381934
• Report Number: 9611530-2014-00030
• 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
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 04/29/2014
• Distributor Facility Aware Date: 04/03/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/29/2014
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2008
• 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: 74 YR
• Patient Weight: 84