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 2019-05-31 for PARKER BATH AL14010-US manufactured by Arjo Hospital Equipment Ab.
[147323030]
(b)(4). Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment ab (under registration #(b)(4)). As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4). Additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[147323031]
Arjo was requested for a service of the parker bath. Upon visit at the customer facility and the evaluation the arjo qualified representative found that the door will drop when let go due to unscrewed top of the gas strut. The customer was unaware of the issue. The device was repaired and put back to use. No injury or adverse event occurrence was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00087 |
| MDR Report Key | 8657215 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-31 |
| Date of Report | 2019-07-26 |
| Date of Event | 2019-05-07 |
| Date Facility Aware | 2019-05-12 |
| Report Date | 2019-07-26 |
| Date Reported to FDA | 2019-07-26 |
| Date Reported to Mfgr | 2019-07-26 |
| Date Mfgr Received | 2019-05-12 |
| Device Manufacturer Date | 2004-06-28 |
| Date Added to Maude | 2019-05-31 |
| 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 | 2019-05-31 |
| Model Number | AL14010-US |
| Device Availability | Y |
| Device Age | 15 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 | 2019-05-31 |