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 2019-02-28 for SYSTEM 2000 AR31801US1010 manufactured by Arjohuntleigh Polska Sp Z O.o..
[141220709]
(b)(4). The defective bath was removed from usage and evaluated by the qualified (b)(4)representative. According to the results, the washer of the left screw holding the tub shell was damaged, which led to detachment of the tub shell's left side. The tub shell was also cracked on the right side due to the weight of water and lack of proper support on the left side. The shell did not fully detach and did not fall to the floor. The involved device was not under the (b)(4) service agreement, but was serviced internally by the customer. The investigation is ongoing and further information will be provided within the next report.
Patient Sequence No: 1, Text Type: N, H10
[141220710]
(b)(4) was notified about an event with involvement of system 2000 bath. It was reported that the caregiver was in the process of moving the patient with the ceiling lift (prior to moving the patient to the bath), when the tub shell came loose on the left side. The tub shell also cracked on the right side, which caused water to spill to the floor. The caregiver pulled back the patient, who was still in the lift's sling moving in position for bath. The patient was not injured. The caregiver reported a back pain and anxiety and consulted a doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00034 |
| MDR Report Key | 8377087 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-28 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-02-17 |
| Date Facility Aware | 2019-02-18 |
| Report Date | 2019-03-15 |
| Date Reported to FDA | 2019-03-15 |
| Date Reported to Mfgr | 2019-03-15 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2016-01-08 |
| Date Added to Maude | 2019-02-28 |
| 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 | ARJOHUNTLEIGH POLSKA SP Z O.O. |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 2000 |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2019-02-28 |
| Model Number | AR31801US1010 |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP Z O.O. |
| Manufacturer Address | KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-28 |