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 2018-02-23 for MALIBU AJR7112-GB manufactured by Arjo Hospital Equipment Ab.
[101146054]
(b)(4). Additional information will be provided upon investigation conclusion.
Patient Sequence No: 1, Text Type: N, H10
[101146055]
On 2018-jan-24 arjohuntleigh was notified by customer facility about event with involvement of malibu bathtub (serial number: (b)(4)), which occurred on (b)(6) 2018. The customer facility employees found that the bath chair was sitting at an angle and discovered that the chair safety clip appeared to be reversed. At this time no patient was on the chair, but it was not confirmed if the bath was used for therapy. When on 2018-jan-25 the arjohuntleig representative attended customer facility, no issues were found. The customer facility representative confirmed that they had refitted the safety clips on both baths.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00047 |
| MDR Report Key | 7293012 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-02-23 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-01-12 |
| Date Facility Aware | 2018-01-24 |
| Report Date | 2018-04-13 |
| Date Reported to FDA | 2018-04-13 |
| Date Reported to Mfgr | 2018-04-13 |
| Date Mfgr Received | 2018-02-24 |
| Device Manufacturer Date | 2003-11-10 |
| Date Added to Maude | 2018-02-23 |
| 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 | 2018-02-23 |
| Model Number | AJR7112-GB |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 14 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 | 2018-02-23 |