MAUDE Adverse Event Report: INVACARE CONTINUING CARE CS7 ELEC BED 7 - 30 IN; INVACARE(R) CARROLL CS SERIES(TM) BED

Model Number NA:IHCS7

Device Problem Entrapment of Device (1212)

Patient Problem Death (1802)

Event Date 08/06/2017

Event Type  Death  

Manufacturer Narrative

Multiple attempts have been made by invacare consumer affairs to both the dealer, (b)(4) and the administrator at the (b)(6) centre, for information relating to the mattress and assist rails and further information on how the event happened.(b)(4) identified the serial number for the assist rails on the bed which match the bed.No other response has been received from either party.The mattress dimensions, make, model and manufacturer are still unknown at this time.There is insufficient information provided to determine that the mattress on the bed at the time of the event was an invacare product.The facility was allegedly troubleshooting the event.This ihcs7 electric bed was manufactured by invacare continuing care (aka carroll healthcare - (b)(4)) on july 22, 2013 making the unit 4 years 1 month in age at the time of this event.The bed was shipped as a package which included the ihcs7 bed and the ihcsrlas assist rails.The ihcsrlas assist rails mount to the mid section of the ihcs7 bed.No mattress was included in the original shipment.Should additional information become available, a supplemental record will be filed.

Event Description

The dealer reported on (b)(6) 2017 that a resident at the (b)(6), a geriatric care facility located in (b)(6), got their head stuck between the mattress and rail on an ihcs7 electric bed and passed away.

Manufacturer Narrative

Additional information was obtained.The cs7 bed was on its lowest position on the floor and the head of the bed was between 45 to 90 degrees.The bed was using carroll assist rails (1/2 half rail) attached at the middle part of the frame.There was a remote control in its appropriate holder and attached to the rails.The mattress was a zenith trigel therapeutic support surfaces with dimensions of 79 inches x 35 inches x 6 inches.The mattress is not an invacare product.

• Brand Name: CS7 ELEC BED 7 - 30 IN
• Type of Device: INVACARE(R) CARROLL CS SERIES(TM) BED
• Manufacturer (Section D): INVACARE CONTINUING CARE; 994 hargrieve road; london, ontario
• Manufacturer (Section G): INVACARE CONTINUING CARE; 994 hargrieve road; london, ontario
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 4403296021
• MDR Report Key: 6851956
• MDR Text Key: 85354214
• Report Number: 3003433498-2017-00004
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:IHCS7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2013
• 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
• Patient Outcome(s): Death