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 2018-08-27 for PARKER BATH PB007B manufactured by Arjo Hospital Equipment Ab.
[118262734]
(b)(4).. Additional information will be provided upon the investigation conclusion.
Patient Sequence No: 1, Text Type: N, H10
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Arjo was informed about an issue involving parker bath. It was reported that during inspection the door gas strut was missing, which allowed the door to free fall and not stay in any desired position. The bathtub was used by the customer facility. No injury occurrence was reported. The bathtub was manufactured approximately 29 years ago and it was advised the customer facility to remove the bathtub from use due to the found malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00173 |
| MDR Report Key | 7817532 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-08-27 |
| Date of Report | 2018-09-25 |
| Date Facility Aware | 2018-07-31 |
| Report Date | 2018-09-25 |
| Date Reported to FDA | 2018-09-25 |
| Date Reported to Mfgr | 2018-09-25 |
| Date Mfgr Received | 2018-07-31 |
| Date Added to Maude | 2018-08-27 |
| 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 | 2018-08-27 |
| Model Number | PB007B |
| Device Availability | Y |
| Device Age | 29 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-27 |