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 2018-05-14 for MALIBU AZR23110-GB manufactured by Arjo Hospital Equipment Ab.
[108154823]
(b)(4). (b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[108154824]
Arjo was notified about an event with involvement of malibu bathtub, where it was reported that device almost tipped over during use. After the bathtub was drained of water the caregiver was transferring the patient sitting on the chair out of the bathtub. When the chair was already out of the bath, the device started to tip over and the patient slid from the chair. The caregiver held the bath to stop it falling onto patient and called for assistance. When it came bathtub was put in an upright position. The involved patient did not sustain any injury. The caregiver had a sore back. According to provided information no treatment was applied to caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00106 |
| MDR Report Key | 7510091 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-14 |
| Date of Report | 2018-06-08 |
| Date of Event | 2018-04-17 |
| Date Facility Aware | 2018-04-18 |
| Report Date | 2018-06-08 |
| Date Reported to FDA | 2018-06-08 |
| Date Reported to Mfgr | 2018-06-08 |
| Date Mfgr Received | 2018-04-18 |
| Device Manufacturer Date | 2018-08-17 |
| Date Added to Maude | 2018-05-14 |
| 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 |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-05-14 |
| Model Number | AZR23110-GB |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | Y |
| Device Age | 8 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 | 2018-05-14 |