MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-06-17 for SYSTEM 2000 AP32311-EU manufactured by Arjohuntleigh Polska Sp. Z O.o..
[47597670]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[47597671]
It was initially reported to arjohunteigh representative that: "client was in bath, bath was filled to highest level. Bath seems to move to one side, water flows over, client was in it, bath moved back to its position. "
Patient Sequence No: 1, Text Type: D, B5
[54925504]
An investigation was carried out into this complaint. When reviewing similar reportable events for system 2000 we have found a very low number of other similar cases - tub was tipping during use. The device was being used for the patient therapy. The bath was filled to highest level and seems to move to one side, water flows over, bath moved back to its position- in that way it contributed to the event. The described problem occurred only once and information provided in incident description form (idf) suggest that device was in good working condition and all functions work as intended. The technicians try to recreate the event. Several actions were made to try to simulate the situation again. Without positive result. Technicians checked bath configuration, length chassis and bath, that was correct. The only situation which was simulated and confirm customer statement was when the bath was filled till maximum level (few cm under the top bath tub) and technicians placed 85 kg weight on the end of the bath. Then one leg become loose from the floor. All devices are equipped with instruction for use (ifu) which clearly inform how to correctly use and maintenance the product. Ifu for system 2000 (04. Ar. 09) once a week caregiver should: "visually check hoses, pipes and connections. Visually inspect for leaks of any kind by looking under tub, lid behind the panel. " equilibrium calculation has been establish on system 2000 tubs and included in test report (b)(4) dated on 2007-04-04. An equilibrium calculation on the three models 20, 23 and 25 was made to investigate the risk of the tub tipping over. The criteria was that a person weighing 182kg should be able to stand in a tub filled with water at the position where the back slope begins without any risk for the tub to tip over. The calculations shows that all the models reach the set criteria. Calculations are made to verify the strain that the tub expose on the floor. From this we can conclude that it is not likely that tub legs could raise by itself during normal use of the product. From all of above information we could not determine the exact root cause of the failure. It can be established that the bath was being used for patient handling but it appears that the device was according to specification when the event occurred. The device was in good working condition. Therefore the device played a role in the event but not as result of a malfunction. Moreover technicians managed to recreate the event only situation when bath was fill to maximum level and all weight was placed on the end of the bath. Please note, that if caregiver would have followed every guideline given in instruction for use there would have been no user at risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00113 |
| MDR Report Key | 5731803 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-17 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-05-20 |
| Date Facility Aware | 2016-05-20 |
| Report Date | 2016-08-05 |
| Date Reported to FDA | 2016-08-05 |
| Date Reported to Mfgr | 2016-06-17 |
| Date Mfgr Received | 2016-05-20 |
| Device Manufacturer Date | 2010-01-21 |
| Date Added to Maude | 2016-06-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO, TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 2000 |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-06-17 |
| Model Number | AP32311-EU |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-17 |