MAUDE Adverse Event Report: HILL-ROM LAY FLAT RECLINER; CHAIR, HOSPITAL

Model Number P9084

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 09/26/2017

Event Type  malfunction  

Event Description

Patient stated that he was in the cardiac chair and the back of the chair fell back, causing him to go back with the chair, stretching his abdomen and hitting the back of his head.He stated this was painful to his abdomen.The chair was assessed by the patients nurse.The chair is designed to go back flat as a safety precaution for cpr.There is a button for you to push to make this happen and it is located just under the armrest of the chair.It would be possible for the patient to hit this button, causing the chair back to go flat rapidly.The event not witnessed by staff but two nurses responded.They assisted the patient to sit up and assessed the chair, which seemed to be working properly.The patients chair was not near the wall and there was 12 inches of clearance between the chair and the wall.The patient had a wound vac in place on his abdomen that was intact and functioning properly.There was no apparent injury to the patient.Chair was tagged and moved to facilities to be evaluated before being returned to service.

• Brand Name: LAY FLAT RECLINER
• Type of Device: CHAIR, HOSPITAL
• Manufacturer (Section D): HILL-ROM; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6954848
• MDR Text Key: 89513914
• Report Number: 6954848
• Device Sequence Number: 1
• Product Code: INN
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P9084
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• 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 Age: 54 YR