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

Model Number AL14110-US

Device Problem Device Fell (4014)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the performed inspection the door gas strut was defective and there was an oil leakage found on the part.The faulty gas strut was replaced.The investigation is on-going and additional information will be provided in the next report.

Event Description

Arjo was notified that during inspection of the parker bath, the device door was unable to remain in upright position and was falling when raised.The customer facility was not aware of the malfunction.No injury occurrence was reported.

Manufacturer Narrative

An arjo service technician during an annual preventive maintenance of parker bath 420, discovered that bath doors would not stay in raised position and would fell fast.As per the service technician the gas strut (a bath component used for door attachment to the bath) leaked out, an oil was visible on the bottom of the gas strut.The faulty part was disposed of after the repair.According to the technician the customer was not aware of the issue and no injury was reported in relation to this failure.The investigation revealed that at the moment of failure, the parker bath 420 was 12 years and 9 months.As per the available operating and product care instruction (ifu; 04.Al.004 us, ca dated april 2007) "the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventive maintenance as specified in this manual"; "parker bath is subject to wear and tear and the following actions must be performed when specified to ensure that the product remains within its original manufacturing specification".Part of the device maintenance is replacement of the gas strut every 3rd year.According to the service technician the faulty gas strut looked like the original one, and it is unknown if the gas strut was ever replaced.Therefore, from the above it can be stated that the reported failure might be related to normal wear and tear of the component.In summary, the device failed to meet its specification since the door did not maintain their position, from that perspective the device was directly involved in the reported issue however it was not use for treatment when the failure was discovered.There was no adverse user outcome.Taking into account symptom of fast fall of doors, it was decided to report this failure in abundance of caution.Arjo will continue to evaluate each case individually and continue to report events as required.

• Brand Name: PARKER BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• MDR Report Key: 8891951
• MDR Text Key: 199115117
• Report Number: 3007420694-2019-00134
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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: AL14110-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other