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

Model Number AL14010-CA

Device Problem Component Falling (1105)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).Additional information will be provided upon the investigation conclusions.

Event Description

Arjohuntleigh received a customer complaint on parker bath, where it was reported that the tub door was falling heavily.According to the provided information no patient was involved in the event and no injury was reported.

Manufacturer Narrative

Arjo received a customer complaint on parker bath, where it was reported that the tub door was falling (not keeping the upright position) due to worn gas strut.Regardless of the malfuntion, the bathtub was still used by the customer facility.No event was experienced by the device's users, no harm was reported.The previous bathtub preventive maintenance was performed by arjo representative on (b)(6) 2018.According to the service report some maintenance actions were carried out but none of them was directly related to the door gas strut malfunction.Only door latch and door seal were checked and none malfunction was reported.The arjo representative also adjusted anti-scalding protection, replaced push fit airjet assembly, checked drain for leakages and lubed the actuator.Based on the service summary no other issue was indicated.The review of similar reportable events with the involvement of the parker bath in last 5 years revealed a low number of complaints related to the situation where the defective door gas strut contributed to an event occurrence.The malfunction was detected during servicing of the device by arjo representative.As a correction action, the worn gas strut was replaced.According to arjo technician opinion, the faulty gas strut had low resistance.The review of service history for the bathtub confirmed that door gas strut was replaced on (b)(6) 2012, so over 5 years ago.Therefore its defect most likely was a consequence of the normal wear after years of usage.The parker bath is subject to wear and tear, and recommended maintenance instructions must be performed when specified to ensure that the equipment remains within its original manufacturing specification.List of recommended steps can be found in product preventive maintenance schedule active at the time when this device was manufactured (pm0684_01 dated on december 2002).In order to ensure the efficiency and functionality of the door strut, this particular component should be checked every 12 months according the following instruction: "open the door and check that the gas strut holds the door in the upright position and does not drop." it informs also that the door strut should be replaced after 48 months/4 years of functioning.Please note that operating and daily maintenance instructions (ifu, pm0607_02 dated on march 2002) delivered with the device, includes information which each user of the arjo equipment should follow.In connection with the subject of this investigation, the following warnings were established to prevent from any injury occurrence (p.4): "always ensure that the equipment is handled by trained staff." "always ensure that the bathers limbs are clear of the door before closing." "always keep fingers clear of the door when closing." the preventive maintenance schedule also reminds the customer to check operation of the door regularly on a weekly basis to detect any failure related to this assembly: "open and close the door and check the lock and supporting gas strut for correct and smooth operation." (p.6) following the collected information it can be determined that the preventive maintenance of the involved unit was not correctly performed.Therefore the most likely root cause for this case is related to maintenance deficiencies.At the time of event the device did not meet manufacturer specification due to worn door gas strut.This however did not caused or contribute to adverse event.It was unknown if the bathtub was used for patient hygiene.We report this incident in abundance of caution due to malfunction which could pose a risk for device users.

• 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: 7464029
• MDR Text Key: 106721999
• Report Number: 3007420694-2018-00103
• 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: 05/25/2018

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: AL14010-CA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2018
• Distributor Facility Aware Date: 04/03/2018
• Device Age: 15 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/25/2018
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other