MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH

Model Number 420*

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 Date 02/24/2014

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh rep who visited the customer site and inspected the device, as documented in the complaint file, that jet cap came off resulting in injury to pt."two baths took place in quick succession.The hydrotherapy feature was used on both baths." 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.Because of that and (b)(4) requirements (exceeded lifetime) it has been decided to report this event only in united states.Risk analysis also refers to described event where serious injury can occur, because of this we have decided to consider this complaint to be reportable.Ref # mfr 9611530-2014-00079.

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvegan 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3737986
• MDR Text Key: 19920686
• Report Number: 1419652-2014-00079
• Device Sequence Number: 1
• Product Code: ILM
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014,02/25/2014

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 420*
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2014
• Distributor Facility Aware Date: 02/25/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 93