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 2019-04-04 for MALIBU AZR23110-GB manufactured by Arjo Hospital Equipment Ab.
[140870344]
(b)(4). The involved bathtub was taken out of use after the event and it was evaluated by the arjo qualified representative. According to the inspection summary the device was in good condition and fully functional. No malfunction that could lead to the alleged sudden descent of the chair or its stuck during transfer was detected. It was decided to replace the chairlift actuator as a precaution. After replacing the chair lift actuator the device was tested and was confirmed to meet the manufacturer's specification. The investigation is on-going and additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[140870345]
It was reported that when caregivers were trying to bath the resident, the chair arm stopped working during the chair swing moment. The seat position was roughly halfway between fully out and fully in when it stuck. The caregivers securely removed the patient from the chair with the overhead hoist in bathroom. According to the received information, when the resident was taken off, the chair suddenly dropped to its lowest point. No injury occurrence was indicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00057 |
| MDR Report Key | 8481739 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-29 |
| Date Facility Aware | 2019-03-08 |
| Report Date | 2019-04-29 |
| Date Reported to FDA | 2019-04-29 |
| Date Reported to Mfgr | 2019-04-29 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2013-02-12 |
| Date Added to Maude | 2019-04-04 |
| 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, SITZ, POWERED |
| Product Code | ILM |
| Date Received | 2019-04-04 |
| Model Number | AZR23110-GB |
| Device Availability | Y |
| Device Age | 6 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 | 2019-04-04 |