MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. PARKER BATH; ILJ

Model Number AL11500-GB

Device Problems Use of Device Problem (1670); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Fall (1848); Injury (2348)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh polska sp.Z.O.O.(registration # (b)(4) on behalf of the importer arjohuntleigh, inc.(ahus) (b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

Initially it was reported to arjohuntleigh representative that "the caregiver was showering a patient and tripped over the hot & cold supply hoses at the end of the bath".Caregiver sustained injury to the lower back muscle.Gp referred her for x-ray.No additional information known at this time.

• Brand Name: PARKER BATH
• Type of Device: ILJ
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5488420
• MDR Text Key: 39935532
• Report Number: 3007420694-2016-00028
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/09/2016,02/22/2016

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?: No
• Device Operator: Other Caregivers
• Device Model Number: AL11500-GB
• 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: 03/09/2016
• Distributor Facility Aware Date: 02/22/2016
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/09/2016
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2010
• 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