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 2018-11-15 for PARKER BATH AL11501-GB manufactured by Arjo Hospital Equipment Ab.
[127871845]
(b)(4). Additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[127871846]
It was reported by the customer facility that parker bath door keeps slamming shut due to the door gas strut fault. No injury occurrence was indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00217 |
| MDR Report Key | 8072918 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-11-15 |
| Date of Report | 2018-12-14 |
| Date Facility Aware | 2018-10-17 |
| Report Date | 2018-12-14 |
| Date Reported to FDA | 2018-12-14 |
| Date Reported to Mfgr | 2018-12-14 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2005-03-14 |
| Date Added to Maude | 2018-11-15 |
| 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 | PARKER BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-11-15 |
| Model Number | AL11501-GB |
| Device Availability | Y |
| Device Age | 13 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 | 2018-11-15 |