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

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Overdose (1988)

Event Date 02/04/2015

Event Type  Injury  

Event Description

It was reported by the user facility that they believe it is too easy to switch the scale from measuring in pounds to kilograms.The user facility has all of their beds locked to kilograms, however, they had an event where the scale was measuring in pounds.As a result, they report a pt was allegedly overdose with warfarin for 3 days.Once the issue was discovered, the pt was administered a coagulant.No further medical intervention was reported.No malfunction of the device is alleged.

• Brand Name: SPIRIT SELECT
• Type of Device: FNL, 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 ; 5196914119
• MDR Report Key: 4661145
• MDR Text Key: 16863670
• Report Number: 1831750-2015-00100
• 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: Distributor
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2015
• Distributor Facility Aware Date: 02/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2015
• Date Manufacturer Received: 02/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention