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 2016-06-30 for SYSTEM 2000 AP31801US1010 manufactured by Arjohuntleigh Polska Sp. Z O.o..
[48510963]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[48510964]
The arjohuntleigh has been informed that the bath tilted towards the doorway when it got caught on a container that was by the head of the tub.
Patient Sequence No: 1, Text Type: D, B5
[50640860]
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 due to misuse. The device was being used for the patient therapy. The caregiver did not notice that sharp container was situated under the bath. While caregiver was lowering the bath onto obstruction bath tilted forwards and in that way contributed to the event. The bath was according to the specification in time when the event occurred. The device was in good working condition. The customer was managed to recreate the event. All devices are equipped with instruction for use, which clearly inform how to correct use and maintenance the bath. Instruction for use for system 2000 contains warnings which clearly inform that: "to avoid entrapment of the patients or caregivers legs or feet, make sure that they are kept clear of all obstacles. " "to avoid the device in use from tipping, do not raise or lower other equipment close to it and be aware of stationary object when lowering. " according to the above the device was found to have been to specification when the event took a place. It can be established that bath was being used for patient handling but it appears it contributed to the event likely due to a use error the device was according to specification when the event occurred. The device was in good working condition. The bath tilted forward due to contact with obstruction. 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 | 3007420694-2016-00117 |
| MDR Report Key | 5760988 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-06 |
| Date Facility Aware | 2016-06-06 |
| Report Date | 2016-07-28 |
| Date Reported to FDA | 2016-07-28 |
| Date Reported to Mfgr | 2016-06-30 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2014-11-28 |
| Date Added to Maude | 2016-06-30 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 2000 |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-06-30 |
| Model Number | AP31801US1010 |
| Device Availability | Y |
| Device Age | 18 MO |
| 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 | 2016-06-30 |