MALIBU/SOVEREIGN (INCL. DIGNITY)
Received Nov 26, 2014 · Event occurred Oct 27, 2014
Report 3007420694-2014-00115 · MDR key 4309304
Device
Manufacturer
Arjohuntleigh Polska Sp. Zo.o.Model number
AZL23115-EUProduct problems
- Device Tipped Over
- Installation-Related Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION INCLUDING ACTUAL DEVICE EVALUATION. (B)(4).