MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PARKER BATH

Model Number AL24010-CA

Device Problem Unintended Movement (3026)

Patient Problems Muscle Weakness (1967); Injury (2348)

Event Type  Injury  

Event Description

Ref imp# (b)(4).

Manufacturer Narrative

(b)(4).Add'l info will be provided upon completion of the mfr's investigation.General condition of the device that was described in the incident description form (idf) was good.Some scratches were found in the fiberglass, that may have been caused by pulling outward on the door while lowering.Functional test showed that all functions worked as they should - arjohuntleigh rep pulled himself up on back of tub to see if he could elevate or move tub.He noticed some movement but tub did not come off of the floor.He also tried to move side to side and tub would not move, he emptied the water and was able to move the tub side to side but not back to front.He could not get the tub to tip.

• 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, box 61; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 welmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3913793
• MDR Text Key: 4670942
• Report Number: 9611530-2014-00035
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AL24010-CA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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