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 2016-06-24 for SYSTEM 2000 AD31801US1011 manufactured by Arjohuntleigh Polska Sp. Z O.o..
[48105111]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[48105112]
It was initially reported to arjohuntleigh representative that: "a disoriented resident went into the tub room and climbed in the tub and pressed the fill button. Staff could not get in as door was locked from the inside. The manager was walking by, heard water running and found a way to unlock the door. The water was about 2 inches below the edge of the tubshell at this time, since the autofill did not shut off the filling of the tub. The water was drained and the resident was fine. "
Patient Sequence No: 1, Text Type: D, B5
[54589865]
An investigation was carried out into this complaint. When reviewing similar reportable events for system 2000 we have found only one complaint related to issue where the patient snap in the bathroom and start therapy without caregiver permission. The device was being used for the patient therapy- disoriented resident snap in the bathroom, pressed the fill button and went into the bath. Staff could not get in, as door was locked from the inside and in that way it contributed to the event. That patient has been left without caregiver when the event occurred. The bath has been out of the specification in the time when the event occurred due to fact that autofill function did not work correctly. All devices are equipped with instruction for use which clearly inform how to correct use the device. Ifu for system 2000 contains information: "this equipment is intended for therapeutic bathing and showering hospital or care facility resident sunder the supervision of trained skilled nursing staff in accordance with the instructions outlined in the instructions for use (ifu). All other uses must be avoided. " warning: - "to avoid injury, make sure that the patient is not left unattended at any time. " moreover the ifu contains preventive maintenance section which clearly inform that: -once a week caregiver should "perform functionality test" 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. Patient has been left unattended during therapy. Please note that if caregiver would have followed every guideline given in instruction for use (patient is not left unattended) there would be no user at risk. Due to the nature of this incident we are reporting this event to competent authorities in the abundance of caution - even though no injury occurred, there was a probability of harm with a high severity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00116 |
| MDR Report Key | 5747817 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-24 |
| Date of Report | 2016-06-14 |
| Date Facility Aware | 2016-06-14 |
| Report Date | 2016-06-24 |
| Date Reported to FDA | 2016-06-24 |
| Date Reported to Mfgr | 2016-06-24 |
| Date Mfgr Received | 2016-06-14 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2016-06-24 |
| 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 | 2016-06-24 |
| Model Number | AD31801US1011 |
| Device Availability | Y |
| Device Age | 11 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 | 2016-06-24 |