MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS FULL ELECTRIC FOOT SPRING 9153638201; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number G5510

Device Problems Device Stops Intermittently (1599); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

A return was issued and the product is awaiting receipt and/or evaluation. a follow up will be filed if/when any additional information is provided.

Event Description

The bed works intermittently, jerks when the bed is raising, and the head and foot motors would start sparking.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: beds, mattresses, rails.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 for the observable sparks between the foot section and the actuators also the complaint of intermittent power was confirmed due to the head and foot sections not raising when both actuators were connected to the circuit.This is due to the short circuits within the actuators.Complaint was confirmed.The underlying cause is short circuits within the actuators.Root cause could not be determined after reviewing the documentation in this investigation.

Event Description

The return fields in oracle state: beds, mattresses, rails.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 for the observable sparks between the foot section and the actuators also the complaint of intermittent power was confirmed due to the head and foot sections not raising when both actuators were connected to the circuit.This is due to the short circuits within the actuators.The bed works intermittently, jerks when the bed is raising, and the head and foot motors would start sparking.

• Brand Name: FULL ELECTRIC FOOT SPRING 9153638201
• 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: 5566875
• MDR Text Key: 42960587
• Report Number: 1031452-2016-01309
• 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: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G5510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• 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