MAUDE Adverse Event Report: PENNER MANUFACTURING PENNER; WHIRLPOOL CHAIR AND BELT

Model Number 389000-1

Device Problems Safety interlock(s) inadequate (2167); Device Issue (2379)

Patient Problems Fall (1848); Respiratory Distress (2045)

Event Date 02/11/2014

Event Type  Death  

Event Description

On (b)(6) 2014 at 8:50 pm, resident was taken from her room in the whirlpool chair to the whirlpool.The resident was receiving a whirlpool given by cna when the resident "lurched forward" in the water.Cna asked the resident to sit back and at that time decided to shorten her whirlpool.As cna was missing the resident up out of her whirlpool, the resident "lurched forward" again and went head first into the whirlpool, with her bottom up.Cna called for assistance over the walkie talkie immediately.Staff arrived quickly to assist with removing the resident from the water.The water was immediately started to drain and staff worked at getting the resident out of the water using a hoyer lift.After the resident was brought out of the water, she was breathing, spitting water and asked for a drink of water.The resident was cyanotic.No resuscitative efforts were given.Staff called the rescue squad and the resident was transferred to the emergency room.On (b)(6) 2014, it was reported, the resident passed away on (b)(6) 2014.

• Brand Name: PENNER
• Type of Device: WHIRLPOOL CHAIR AND BELT
• Manufacturer (Section D): PENNER MANUFACTURING; 102 grant st; aurora NE 68818
• MDR Report Key: 3688178
• MDR Text Key: 4242230
• Report Number: 3688178
• Device Sequence Number: 1
• Product Code: ILJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2014,02/26/2014

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: Health Professional
• Device Model Number: 389000-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2014
• Device Age: 11 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Weight: 95