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 2019-04-08 for SYSTEM 2000 AP32811EU1010 manufactured by Arjohuntleigh Polska Sp Z O.o..
[141210069]
(b)(4). The device was evaluated by the arjo qualified representative. According to the results of inspection, no electrical malfunction was detected. The investigation is on-going and additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[141210070]
Arjo was notified by the customer facility that there were electrical breakdowns to the casing of the bathtub. It was reported that the nurse felt like she received an electric shock, when she touched a part of the bathtub.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00061 |
| MDR Report Key | 8491069 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-08 |
| Date of Report | 2019-06-06 |
| Date Facility Aware | 2019-03-13 |
| Report Date | 2019-06-06 |
| Date Reported to FDA | 2019-06-06 |
| Date Reported to Mfgr | 2019-06-06 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2017-11-20 |
| Date Added to Maude | 2019-04-08 |
| 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 | ARJOHUNTLEIGH POLSKA SP Z O.O. |
| Manufacturer Street | KS. 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 | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2019-04-08 |
| Model Number | AP32811EU1010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP Z O.O. |
| Manufacturer Address | KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-08 |