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 2017-09-05 for SYSTEM 2000 AP31801-GB manufactured by Arjo Hospital Equipment Ab.
[85946217]
(b)(4). Additional information will be provided upon conclusions of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[85946218]
Arjohuntleigh has been informed that a system 2000 bath has been tested positive for contamination with pseudomonas. The bath has been taken out of use. No patient was involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00186 |
| MDR Report Key | 6841388 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-09-05 |
| Date of Report | 2017-11-27 |
| Date Facility Aware | 2017-08-23 |
| Report Date | 2017-11-27 |
| Date Reported to FDA | 2017-11-27 |
| Date Reported to Mfgr | 2017-11-27 |
| Date Mfgr Received | 2017-10-05 |
| Device Manufacturer Date | 2006-12-25 |
| Date Added to Maude | 2017-09-05 |
| 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 | 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 |
| Remedial Action | RP |
| 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 | 2017-09-05 |
| Model Number | AP31801-GB |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-09-05 |