MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS SEMI ELECTRIC FOOT SPRING 9153638202; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number VC5310

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Reporter stated that the motor broke while the customer was sitting upright drinking coffee.He stated when it broke it caused him to spill the coffee and burn himself.The dealer was called and he stated it was the head section that fell back down.He states he did have red marks on his body but it was not bad enough to go to the hospital.He states he took a motor off of a bed he had in stock to get the customer up and running and needs a replacement for his stock.No further information.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: beds, mattresses, rails.Junction box, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the bed motor/electronic package's housing breaking at the head spring section connection location.There were no visible flaws in the housing molding.The root cause of failure is inconclusive.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: beds, mattresses, rails.Junction box, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the bed motor/electronic package's housing breaking at the head spring section connection location.There were no visible flaws in the housing molding.The root cause of failure is inconclusive.Reporter stated that the motor broke while the customer was sitting upright drinking coffee.He stated when it broke it caused him to spill the coffee and burn himself.The dealer was called and he stated it was the head section that fell back down.He states he did have red marks on his body but it was not bad enough to go to the hospital.He states he took a motor off of a bed he had in stock to get the customer up and running and needs a replacement for his stock.No further information.

• Brand Name: SEMI ELECTRIC FOOT SPRING 9153638202
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5293431
• MDR Text Key: 34020411
• Report Number: 1031452-2015-17082
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VC5310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• 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