MAUDE Adverse Event Report: ARJO HOSP EQUIPMENT AB PARKER BATH

Model Number AL25110-GB

Device Problem Overfill (2404)

Patient Problem Loss of consciousness (2418)

Event Date 03/23/2015

Event Type  Injury  

Event Description

Initially it was reported by arjohuntleigh's rep that: "client was found unconscious in the water".Caregiver filled footwell of the bath, put client into bath and continued to run water while tilting bath back slightly, caregiver then started to cook client's breakfast, second caregiver walked into home to find client facedown in bath, she immediately called for help and both staff members lifted client out ot the bath and started cpr to resuscitate the client, client came around where they called paramedics and comforted until they attended.The paramedics were called and confirmed she was better to stay in her own environment after they passed her health.Device examination performed with the customer showed that the involved bath is in "excellent condition".Bath operated through all its functions perfectly but when filling autoshop device does not activate so water does not stop until manually operated.The resident was assessed in relation to mobility gallery as "b"- partly capable of performing daily independently and the assistance she requires is not generally physically demanding for the caregiver.

Manufacturer Narrative

(b)(6).Add'l info will be provided following the conclusion of the investigation.

• Brand Name: PARKER BATH
• Manufacturer (Section D): ARJO HOSP EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSP EQUIPMENT AB; verkstadsvagen 5; selov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4664051
• MDR Text Key: 5733376
• Report Number: 3007420694-2015-00066
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AL25110-GB
• 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: 04/01/2015
• Distributor Facility Aware Date: 03/23/2015
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/01/2015
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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): Required Intervention
• Patient Weight: 38