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 2018-10-10 for MALIBU/SOVEREIGN AZL33216-GB manufactured by Arjo Hospital Equipment Ab.
[123690536]
(b)(4). The collected information is under further review. Additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[123690537]
It was reported that nurse received an electric shock from the lift arm, when trying to move it manually. No patient was involved. There is no indication of any injury or medical treatment. The device was taken out of use and inspected by arjo representative. The fault could have not been replicated. The bath was tested for an electrical safety on all metal parts and it passed all tests. It was suspected that this was a static electric shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00196 |
| MDR Report Key | 7951287 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-09-21 |
| Date Facility Aware | 2018-09-24 |
| Report Date | 2018-10-31 |
| Date Reported to FDA | 2018-10-31 |
| Date Reported to Mfgr | 2018-10-31 |
| Date Mfgr Received | 2018-09-24 |
| Device Manufacturer Date | 2009-10-26 |
| Date Added to Maude | 2018-10-10 |
| 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 | MALIBU/SOVEREIGN |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-10-10 |
| Model Number | AZL33216-GB |
| Device Availability | Y |
| Device Age | 9 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 | 2018-10-10 |