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 2019-01-18 for PARKER BATH AL14110-EU manufactured by Arjo Hospital Equipment Ab.
[134572175]
(b)(4). Arjo representative evaluated the device in question. The gas strut head was loose because of the absence of a locknut. The gas strut head was disassembled and the door was completely free, so it was closing heavy. The bathtub was not removed from use by the customer facility despite the problem. The defective part was replaced by the arjo representative. Additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[134572176]
It was reported that during inspection requested by the customer facility, the arjo qualified representative detected the defect of the bath's door gas strut. The malfunction resulted in the door unable to remain in required position and closing fast. The bathtub was used by the customer despite the malfunction. No information regarding an injury occurrence was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00018 |
| MDR Report Key | 8259961 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-18 |
| Date of Report | 2019-03-08 |
| Date Facility Aware | 2018-12-20 |
| Report Date | 2019-03-08 |
| Date Reported to FDA | 2019-03-08 |
| Date Reported to Mfgr | 2019-03-08 |
| Date Mfgr Received | 2018-12-20 |
| Device Manufacturer Date | 2005-11-14 |
| Date Added to Maude | 2019-01-18 |
| 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 | 2019-01-18 |
| Model Number | AL14110-EU |
| 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 | 2019-01-18 |