MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH

Model Number AL14110-US

Device Problems Installation-Related Problem (2965); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/12/2013

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that the resident was scalded during bathing procedure.The resident was physically dependent (stroke victim), but was able to somehow make it known that the water was hot.From the received information, the resident sustained 2nd degree burns and was hospitalized."they had the foot of the tub full of water and put the resident in the tub started to fill the tub the rest of the way when the resident started to yell, the caregiver felt the water and it was too hot so she turned the water to cold and the water coming out the cold side was hotter than the hot side.The water coming out of the cold water side i was told was 140 degrees f or higher.(b)(6) said the water was so hot coming from the cold side it melted the flush valves in the toilets.So as the water was still filling she was lifting him out of the tub with a lift at the same time.A function tested included in the incident description form showed that tub was in good to fair condition.Arjohuntleigh representative tested the fill and the shower water temp got to 102 (f) at the max temp and 88 (f) at the bottom.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for parker bath we have found a very low number of other similar cases where there was risk to the patient because of too hot water.We have been able to establish that there is no complaint trend concerning these kind of events.Please note that arjohuntleigh manufactured about (b)(4) parker baths to date.The device was inspected by an manufactured representative at the customer site and found to be to the specification.The device was being used for patient handling and in that way contributed to the event.Instructions for use (ifu - operating and product care instructions 04.Al.00/4 us, ca from april 2007) provides information about safe and correct use of the product.It informs that parker must be installed by appropriately trained personnel according to the assembly and installation instructions.Instructions includes warnings concerning checking water temperature: "always check the water temperature prior to placing bather in the bath or using shower" reported incident occurred in (b)(6) 2013, therefore, above device examination doesn't reflect condition of the device after incident.However, information provided by the originator of this complaint showed that the facility had an issue with the hot water going throughout the entire building and there was no cold water available anywhere.The customer did not notify arjohuntleigh last year because there was nothing wrong with the tub- met its specification.There is also information that the customer is not performing preventive maintenance: "maintenance informed me that he has not read the instruction manual for any preventive maintenance.".

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5,; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5,; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4114149
• MDR Text Key: 4921684
• Report Number: 9611530-2014-00058
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AL14110-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2014
• Distributor Facility Aware Date: 07/16/2014
• Device Age: 5 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/08/2014
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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): Hospitalization