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 2016-05-09 for SYSTEM 2000 AR32212-US manufactured by Arjohuntleigh Polska Sp. Z O.o..
[44689633]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[44689634]
It was initially reported to arjohuntleigh representative that tub tipped over when filled with water. No residents were in tub at the time when incident occured. No staff or damages occurred. This tub was not installed by arjohuntleigh representative as tub was purchased second hand. The examination of the device showed the one leg's bolt was broken.
Patient Sequence No: 1, Text Type: D, B5
[46787197]
An investigation was carried out into this complaint. When reviewing similar reportable events for system 2000 we have found a low number of other similar cases - tub tipped due to broken leg bolt. We have been able to establish that there is no complaint trend concerning these kind of events. The device was inspected by an arjohuntleigh representative at the customer site and found to be out of the specification - broken leg bolt. The device tipped over when filled with water and in that way contributed to the event. From received information no residents were in bath at the time when incident occurred. The root cause of this event appears to be lack of or poorly performed maintenance and wrong installation. Based on reviewing similar reportable events and information provided by arjohuntleigh representative we can conclude that: the bolts fastening the legs to the chassis of the bath can get loose and broken off. The bolt rests on a bushing inside the leg to unload it from the weight of the tub. For a bolt that is not positioned correctly inside the bushing this is the point where the load supplied to the leg is rapidly increased while load comes on it as the bath is being filled. All devices are equipped with instruction for use (ifu) which clearly inform how to safe use the device. Ifu for system 2000 contains information: - "the equipment must be installed according to the assembly and installation instructions, which can only be superseded by local code. The normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instruction, the assembly and installation and the spare part instructions. " section care and maintenance' included in instruction for use informs about recommended actions that should be taken to preserve device safety and performance. In accordance to it, user is obliged: - every week: examine the bath for cracks or other damage. - every month: check that all screws, bolts and other joints are perfectly tight. Device has been in use for over 14 years. Moreover idf contains information that "tub to look aged , rubber trim was loose". Information provided to complaint indicates that bath has not been installed by an arjohuntleigh authorized service technician. During bath examination our technician removed the damaged bolt and discovered that bath was not installed properly. In accordance to our investigation the root cause of this problem is a combination of: - installation error - bolts not correctly tightened during installation - not following recommendation in assembly and installation manual. - not following the ifu with regards to following the maintenance per preventive maintenance schedule (pms) and taking into account the intended device lifetime of 10 years. From above findings we conclude that this incident was caused by user error - the event occur due to not following the instruction for use by caregiver. Bath has not been install by arjohuntleigh authorized service technician. Device inspection confirm that the failure occurred due to wrong installation. Please note, that if caregiver would have followed every guideline given in instruction for use (including safety warnings and importance of performed preventive maintenance) there would have been no user at risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00085 |
| MDR Report Key | 5640234 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-05-09 |
| Date of Report | 2016-04-14 |
| Date of Event | 2016-04-13 |
| Date Facility Aware | 2016-04-14 |
| Report Date | 2016-06-08 |
| Date Reported to FDA | 2016-06-08 |
| Date Reported to Mfgr | 2016-05-09 |
| Date Mfgr Received | 2016-04-14 |
| Device Manufacturer Date | 2001-12-10 |
| Date Added to Maude | 2016-05-09 |
| 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 | 2016-05-09 |
| Model Number | AR32212-US |
| Device Availability | Y |
| Device Age | 14 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 | 2016-05-09 |