MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-23 for SYSTEM 2000 AP31300GB1010 manufactured by Arjohuntleigh Polska Sp Z O.o.
[125101334]
(b)(4). Additional information will be provided upon conclusions of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[125101335]
It was reported that while doing a repair on the bathtub the arjo engineer was re-tightening a screw on the device's control box, when a large spark appeared and the main site circuit breaker tripped. No patient involved. No injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00205 |
| MDR Report Key | 7994522 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-23 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-09-26 |
| Date Facility Aware | 2018-09-26 |
| Report Date | 2019-02-05 |
| Date Reported to FDA | 2019-02-05 |
| Date Reported to Mfgr | 2019-02-05 |
| Date Mfgr Received | 2018-09-26 |
| Device Manufacturer Date | 2017-04-07 |
| Date Added to Maude | 2018-10-23 |
| 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 | 2018-10-23 |
| Model Number | AP31300GB1010 |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-23 |