MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH

Device Problems Component Falling (1105); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Concussion (2192)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh rep that door dropped during use with the pt.After bathing the pt, and whilst drying the pt's feet, the caregiver was hit by the dropping door of the parker bath.Upon arrival of the arjohuntleigh (b)(4), it was determined that the gas strut malfunctioned.The caregiver was examined by a doctor and it was concluded she suffered a concussion.The pt did not suffer any injuries.Caregiver was not hospitalized.Device examination included in incident description form showed that involved device is in good condition.Gas strut was found to be not working correctly - device failed to meet its spec.Provided photos showed that lower part of gas strut's attachment and hinges has rust and signs of wear.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Please note that arjohuntleigh manufactured over 11000 barker baths to date.When reviewing similar reportable events for parker bath, we have found a number of other cases with similar fault description - "door fell down".With the amount of sold devices and with comparison to the daily use of them the trend observed for complaints with this failure mode is considered to be low and acceptable.Regarding the event at hand: the device was inspected by an arjohuntleigh rep at the customer site and found to be out of spec.The device was being used for pt handling and in that way contributed to the event.In accordance to below detailed description: we conclude that this incident was caused by user error - lack of maintenance: gas strut wasn't replaced as recommended by the mfr.The received info and our eval as described above are showing that if the maintenance procedures were followed in accordance to instructions for use or maintenance and repair manual, there would be no pt or caregiver at risk.Please note that this device was in use for about 24 years and after release of above tan, there should have been at least 1 scheduled replacement of gas strut, however from received info regarding maintenance of this parker bath, it wasn't replaced at least since 2005.Even although we cannot rule out a service error, or failure of notifying the customer, we point to the fact that the device was in its third decade of use, a customer notification of 14 years ago was either carried out or not followed, and no related maintenance was done to the device in the past 9 years.We do not have the labelling of 24 years ago but generally at minimum this would highlight the need to exchange worn parts.From this we conclude it is one of the rare cases where a device is being used indefinitely and without maintenance until it breaks down.

• 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: 4172886
• MDR Text Key: 20297186
• Report Number: 9611530-2014-00079
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 10/09/2014
• Distributor Facility Aware Date: 09/09/2001
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/09/2014
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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