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 2019-02-27 for PARKER BATH AL14110-US manufactured by Arjo Hospital Equipment Ab.
[137265704]
(b)(4). Additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[137265725]
The customer facility has requested arjo for service of the parker bath due to the door malfunction. The arjo qualified representative evaluated the claimed device and found that door was dropping down. Further inspection revealed that the gas strut clip is missing, which caused a malfunction. No injury occurrence was reported. It is unknown in what circumstances the malfunction was detected by the customer and if the bath was removed from usage immediately after that.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00033 |
| MDR Report Key | 8373066 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-27 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-01-23 |
| Date Facility Aware | 2019-01-31 |
| Report Date | 2019-03-27 |
| Date Reported to FDA | 2019-03-27 |
| Date Reported to Mfgr | 2019-03-27 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2011-07-12 |
| Date Added to Maude | 2019-02-27 |
| 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 | 2019-02-27 |
| Model Number | AL14110-US |
| Device Availability | Y |
| Device Age | 8 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 | 2019-02-27 |