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 2018-07-16 for SYSTEM 2000 AP31801US0010 manufactured by Arjo Hospital Equipment Ab.
[114434132]
(b)(4). Additional information will be provided upon the investigation conclusion.
Patient Sequence No: 1, Text Type: N, H10
[114434133]
Arjo was informed about an event with involvement of system 2000 bathtub. It was reported that during a bath, the bath began to rise uncommanded to the maximum height with resident in it. It is unknown if the patient was sitting on the bathing lift. The resident was manually removed from the bathtub. No injury was reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00143 |
| MDR Report Key | 7689630 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-07-16 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-06-20 |
| Date Facility Aware | 2018-06-20 |
| Report Date | 2018-08-10 |
| Date Reported to FDA | 2018-08-10 |
| Date Reported to Mfgr | 2018-08-10 |
| Date Mfgr Received | 2018-06-20 |
| Device Manufacturer Date | 2011-09-12 |
| Date Added to Maude | 2018-07-16 |
| 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 | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 2000 |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-07-16 |
| Model Number | AP31801US0010 |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-16 |