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 2016-05-05 for SYSTEM 2000 manufactured by Arjohuntleigh Polska Sp. Z O.o..
[44450891]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[44450892]
It was initially reported that bath was tipping during use. Arjohuntleigh representative was informed by caregiver that patient seat on the end of the bath and was active moving on this point. Patient was left without caregiver during therapy.
Patient Sequence No: 1, Text Type: D, B5
[46505450]
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- during bathing patient seat on the end of the tub and started to active moving. Bath almost tip over, and in that way contributed to the event. It was reported by the caregiver from the facility that patient has been left without caregiver when the event occurred. Moreover further examination by arjohuntleigh's representative revealed no faults within a device - function test showed that the device was working to its specification. No repair or adjustment has been done. The technician has managed to recreate the event: bath has been filled automatically and placed on the highest position. The technician applied their full weight on the tub (the technician's weight is (b)(6)), nothing happened. When the technician hung on and moved up and down violently, the device moved, it was possible to be made to recline. 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 falling, make sure the resident always remains in a seated position. " "to avoid injury, ensure that the resident is not left unattended at any time. " after reviewing the complaint it comes forward that the device was according to specification when the event occurred. The device was in good working condition, no failure was detected. 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. Patient has been left unattended during therapy. Personnel from facility confirm that patient seat on the edge/end of the bath and was actively moving on that point. Please note, that if caregiver would have followed every guideline given in instruction for use (patient is not left unattended, and patient remains in a seated position) there would have been no user at risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00084 |
| MDR Report Key | 5633356 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-04-07 |
| Date Facility Aware | 2016-04-07 |
| Report Date | 2016-06-03 |
| Date Reported to FDA | 2016-06-03 |
| Date Reported to Mfgr | 2016-05-05 |
| Date Mfgr Received | 2016-04-07 |
| Device Manufacturer Date | 2014-01-09 |
| Date Added to Maude | 2016-05-05 |
| 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 | 2016-05-05 |
| Device Availability | Y |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-05-05 |