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 2019-04-15 for PARKER MADISON 530 manufactured by Parker.
[141899298]
(b)(4). The bathtub in question was evaluated by the arjo technician. According to the results of inspection, the support legs on the stretcher support frame were bent. This caused the stretcher legs to catch whilst the bath was being lowered. In consequence this can led them to become detached from the main supports which are attached to the floor. The bath was found to be in poor overall condition due to its age and fact that it has not been serviced for the last 10 years. The customer facility representative stated that similar malfunction (bent stretcher frame) occurred 3 times in the past year, but no indication of any event occurrence was provided. This device is no more manufactured and the parts are not available, so the customer was informed that the bath was not safe to be used. The investigation is on-going and additional information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[141899299]
It was reported that whilst the resident was being removed from the tap end of the stretcher, the frame collapsed and the resident slid down the stretcher bathing platform. The resident was prevented from hitting the floor by the caregiver catching the resident. No injuries were reported. The resident was shocked, but it did not require any treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00065 |
| MDR Report Key | 8513519 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-15 |
| Date of Report | 2019-05-13 |
| Date of Event | 2019-02-20 |
| Date Facility Aware | 2019-03-20 |
| Report Date | 2019-05-13 |
| Date Reported to FDA | 2019-05-13 |
| Date Reported to Mfgr | 2019-05-13 |
| Date Mfgr Received | 2019-03-20 |
| Date Added to Maude | 2019-04-15 |
| 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 | PARKER |
| Manufacturer Street | QUEENSWAY, STEM LANE |
| Manufacturer City | NEW MILTON, HAMPSHIRE BH255NN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BH25 5NN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER MADISON |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2019-04-15 |
| Model Number | 530 |
| Device Availability | Y |
| Device Age | 25 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARKER |
| Manufacturer Address | QUEENSWAY, STEM LANE NEW MILTON, HAMPSHIRE BH255NN UK BH25 5NN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-15 |