MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. MALIBU/SOVEREIGN (INCL. DIGNITY)

Model Number AZL23115-EU

Device Problems Device Tipped Over (2589); Installation-Related Problem (2965)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

Initially, it was reported by arjohuntleigh representative that tub tipped during use.The customer has just received a (b)(4) bath.A local plumber was installing the bath.The day when (b)(4) sales consultant was going to demonstrate the product, he found out that the hand control was not mounted together with the holder for the warm water.There was also leakage at the coupling to the disinfection hose/shower head.Furthermore the bath has not been placed at the place where it should be placed.But the staff were taught according to the circumstances.The local plumber fixed the failures and moved the bath.One week later, the first resident went for a bath.When he/she was finished and should leave the bath it tipped to the side.Device examination showed that it wasn't attached to the floor.No injury occurred as a result of this incident.

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation including actual device evaluation.(b)(4).

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan wielkopolskie 32-0 52; PL 32-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan wielkopolskie 62-0 52; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4309304
• MDR Text Key: 5271948
• Report Number: 3007420694-2014-00115
• 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
• Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AZL23115-EU
• 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
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/26/2014
• 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: 09/01/2014
• 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 Weight: 45