MAUDE Adverse Event Report: STEELCASE, INC. NURTURE CARDIAC CHAIR; CHAIR, EXAMINATION AND TREATMENT

Model Number SC2091R

Device Problems Device Tipped Over (2589); Human-Device Interface Problem (2949); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 10/20/2015

Event Type  malfunction  

Event Description

Patient was moved from bed to chair in the lift sheet.Chair was placed in a flat position when positioning patient.When attempting to raise patient by pulling the small lever and raising patient simultaneously, the chair made a cracking noise and broke, causing the patient's upper body to be tilted downwards.Patient was lifted back onto the bed using the mechanical lift and lift sheet.Patient presumably hit his head although on assessment there is no evidence of injury.Ct head negative.This report entered as a safety concern.Have provided feedback from evaluation: the chair is not defective or broken from what i found.Everything functioned as it was designed.Unlike a bed, where there is support under the entire structure in the flat and in the seating position, a reclining chair does not have this.This chair is designed with a feature to lay flat.I understand that this is to be used in the event where a patient crashes and they need to lie flat quickly, so care can be administered.The version of the story i heard is that patient was transferred from a stretcher to the chair using a bed sheet as a means to carry and transfer this patient.The chair is designed where the arm rest folds down so that a patient can be slid-in from the side.When the patient was transferred to the chair, it was in a reclined position and the side armrest was up, meaning the patient had to be lifted up and over the arm rest.I think the combination of a person being lifted and dropped into the chair in the reclined position made the chair tip backwards because the center of gravity and mass of the patient was beyond the chair's intended design.To prevent this there would need to be a very heavy counter weight in the base of the chair, or it would need to be designed like a bed with support extending under the entire structure.I think if a person was seated in the chair in the upright position and then the chair was made to recline, the person's mass would be positioned where tipping back would not be an issue.

• Brand Name: NURTURE CARDIAC CHAIR
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• Manufacturer (Section D): STEELCASE, INC.; 901 44th st. se; grand rapids MI 49508
• MDR Report Key: 5177052
• MDR Text Key: 29226012
• Report Number: 5177052
• Device Sequence Number: 1
• Product Code: FRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Model Number: SC2091R
• Device Catalogue Number: 3373088
• Other Device ID Number: ORDER #3373088
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2015
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 98