MAUDE Adverse Event Report: CHG HOSPITAL BEDS INC. SPIRIT PLUS; AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Physical Entrapment (2327)

Event Date 01/01/2015

Event Type  Death  

Event Description

It was reported by the user facility that a nurse went to the pt room to check on the pt.The pt was allegedly found deceased, kneeling on the floor, with his head between the left headend and footend siderails.The user facility further reported that the pt, who was admitted for "behavioral issues", was ambulatory and was given the freedom to get out of bed and walk around.The unit involved in the reporter incident was evaluated by the mfr, and no malfunctions or defects were found.

Manufacturer Narrative

The following info was reported by the user facility: the bed was in the low, flat position at the time of the event.; all four siderails were in the raised position at the time of the event.; approx 1 hour had elapsed between the last pt check and discovery.The mfr visited the facility and evaluated the unit involved in the reported incident.The rails latched and functioned properly, and no alignment issues were observed.The cylinder tool specified in iec (b)(4) was used to assess the gap between the rails.The 60mm cylinder tool did not enter the gap between the rails and therefore met the requirement of the standard.No malfunction or defect was found, and no correction required.

• Brand Name: SPIRIT PLUS
• Type of Device: AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CHG HOSPITAL BEDS INC.; 1020 adelaide st. s.; london, on N6E 1R6; CA N6E 1R6
• Manufacturer Contact: paul mitchener ; 1020 adelaide st. s.; london, on N6E 1-R6 ; CA N6E 1R6 ; 6914119
• MDR Report Key: 4491279
• MDR Text Key: 18633693
• Report Number: 3006433555-2015-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 67 YR
• Patient Weight: 75