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 2019-02-22 for PARKER BATH AL27110-EU manufactured by Arjohuntleigh Polska Sp Z O.o..
[136855692]
(b)(4). The device was evaluated by the arjo qualified representative. According to the results of inspection, the door lock mechanism was loose in such a way that the door lock lever has a double angle of up and down movement. If the lever was moved upwards, it was scraping off the protrusion on the door. Another problem is in the pin of the door, the door moves on the pin even when the pin is supported by a stop. The customer requested to exchange the whole device. The investigation is on-going and conclusion is not yet available. Additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[136855693]
It was reported that during use the bath's door lock disengaged, the door flipped out and made a mark on the wall. The customer stated that at the closing of the bathtub by the handle, there are symbols of "locked" and "unlocked" door. The handle always remained within these symbols. However, at this time the customer notice that the handle did not stop at the "locked" symbol, but was going further. Neither patient involvement nor injury occurrence were indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00031 |
| MDR Report Key | 8361269 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-22 |
| Date of Report | 2019-07-05 |
| Date Facility Aware | 2019-01-28 |
| Report Date | 2019-07-05 |
| Date Reported to FDA | 2019-07-05 |
| Date Reported to Mfgr | 2019-07-05 |
| Date Mfgr Received | 2019-06-07 |
| Device Manufacturer Date | 2017-08-07 |
| Date Added to Maude | 2019-02-22 |
| 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 | PARKER BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2019-02-22 |
| Model Number | AL27110-EU |
| 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 | 2019-02-22 |