MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH

Device Problems Detachment Of Device Component (1104); Shelf Life Exceeded (1567); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Type  malfunction  

Event Description

Ref # imp (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for parker bath, we have found low number of other cases with similar fault description - pt sustained skin tear because air jet cup.We have been able to establish that there is very low and decreasing trend that concerns this kind of events.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 there is no particular trend observed for reportable complaints with this failure mode on parker bath.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 pt handling and in that way contributed to the event.From the info rec'd friction burn (abrasion) occurred to the pt as a result of this incident.Pt didn't need hospitalization or treatment because of event, only a dressing was placed on the blister.Described incident and occurred injury have been evaluated by clinical expert (please see conversation attached to complaint file), who stated that above injury is not serious.Risk analysis also refers to described event where serious injury can occur, because of this potential we have decided to consider this complaint to be reportable to the us authorities, but not to the (b)(4) due to the med dev requirements (exceeded lifetime).From above findings we conclude that this incident was caused by a combination of use error - bath wasn't prepared correctly between two baths as recommended in ifu and worn out equipment - the nozzle and cap should be changed at the same time as confirmed by the service technician.Please note also that this device was in use for over 13 yrs.The expected life of this equipment, unless otherwise stated, is ten (10) yrs (from the latest version of instructions for use, however because of similar design to complained bath and the same functionality, life time would be the same for old and new models of parker bath).The issue will be monitored through the arjohuntleigh complaint handling system to closely f/u 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 HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 3737953
• MDR Text Key: 16013085
• Report Number: 9611530-2014-00020
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2000
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1