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 2018-08-17 for PARKER BATH 420.00.01.04 manufactured by Arjo Hospital Equipment Ab.
[117620399]
(b)(4). Arjo was notified about an event with involvement of parker bathtub. It was reported that a resident was standing in the tub and rocking. This caused the bath's tilt actuator to rip out of the tub shell and its material to tear. According to the inspection result there was a 4 inches square hole in the place where the tilt actuator bracket was attached. The tilt actuator was not entirely detached of the tub shell, but a small part of the laminate was still connecting the actuator bracket with the shell. The actuator did not go through to the inner bathtub (the part where patient sits). The functionality test revealed that when the tilt function was activated the actuator was just pushed into that hole and did not change the bath's position as it should. The device was removed from usage. No injury was reported as a result of this complaint. The review of reportable events with the involvement of the parker bath in last years, did not reveal any similar incident. According to the manufacturer's technical opinion the described malfunction causes the bath to be unusable and not stable, so it lost its original functionality. The tilt actuator beside its main role also stabilizes the tub against the unintended tilting. The detachment of this part may result in forward or backward tilting - depending on the weight's position inside the bathtub, which in combination with patient in standing position may result in fall. Please note that the operating and daily maintenance instructions (ifu; (b)(4) rev. 2 issued in march 2002) provided to customer with the involved device informs user about the intended use of the parker bathtub (p. 4): "this equipment is intended for high assistance bathing use in hospital or nursing homes. It should only be used under the supervision of trained skilled staff in accordance with the instructions outlined in the operating and daily maintenance instructions. All other uses must be avoided. " "the bath must be used in accordance with the safety instructions specified in the parker operating manual. " the operating manual also provides instructions for proper transfer and positioning of the patient, which should be followed by the caregivers. Based on the all information collected, the bath was used abusively, which was a direct cause of the occurred malfunction and posed a risk for the resident. Also the lack of proper supervision can be determined as a contributing factor as the resident was standing in the bathtub. Moreover, the bathtub was used not according to its intended use, safety instructions and operating manual recommendation. In conclusion, based on the all available information the malfunction was a result of the abusive use. The technical inspection revealed that the device was not up to manufacturer's specification after the event. According to the customer allegation, the bathtub tilt actuator detached during use. The bathtub was used for a resident hygiene and in that way it played a role in this event. The complaint was decided to be reported to the competent in abundance of caution due to the information that tilt actuator disconnected from the tub shell which could cause a bath instability while the resident was in the bathtub in the standing position.
Patient Sequence No: 1, Text Type: N, H10
[117620400]
Arjo was notified about an event with involvement of parker bathtub. It was reported that a resident was standing in the tub and rocking. This caused the bath's tilt actuator to rip out of the tub shell and its material to tear. No injury was reported as a result of this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00166 |
| MDR Report Key | 7792571 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-17 |
| Date Facility Aware | 2018-07-19 |
| Report Date | 2018-08-17 |
| Date Reported to FDA | 2018-08-17 |
| Date Reported to Mfgr | 2018-08-17 |
| Date Mfgr Received | 2018-07-19 |
| Device Manufacturer Date | 2002-08-01 |
| Date Added to Maude | 2018-08-17 |
| 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 | PARKER BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2018-08-17 |
| Model Number | 420.00.01.04 |
| Device Availability | Y |
| Device Age | 15 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 | 2018-08-17 |