MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH; BATH, HYDRO-MASSAGE

Model Number 420.00.01.04

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

• Brand Name: PARKER BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 7792571
• MDR Text Key: 117620399
• Report Number: 3007420694-2018-00166
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 420.00.01.04
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2018
• Distributor Facility Aware Date: 07/19/2018
• Device Age: 15 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/17/2018
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other