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 Date 06/04/2014

Event Type  Injury  

Event Description

It was initially reported by company rep that during bathing procedure device started to recline on its own."remote would not stop it, tub did not recline enough to spill any water but the resident in tub was close to doing a somersault".The caregiver had to hold the resident down so she did not fall out of tub, then grabbed on to end of hub and pulled up on it.Tub made a beeping sound and then returned to the initial reclined position.The feet of the tub did not lift off the floor, the tub just moved on its axis.From received info injury to the caregiver occurred - pulled muscle or possibly slipped disc in lower back.Caregiver waiting for mri.Ref mfr # 9611530-2014-00035.

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3913855
• MDR Text Key: 15177448
• Report Number: 1419652-2014-00153
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2014

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AL24010-CA
• 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: 06/10/2014
• Distributor Facility Aware Date: 06/04/2014
• Device Age: 1 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 66