MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS HEAD SPRING SCTN-ALL MDLS 9153638197; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5310IVC

Device Problem Crack (1135)

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

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 head section of the bed had a cracked tube.

Manufacturer Narrative

Additional/updated information was added to reflect the head section of the bed being returned to the manufacturer for evaluation.The result of the evaluation was that the drive arm tube was torn, which confirmed the original complaint issue.However, the underlying cause could not be determined.Additionally, the correct brand name, and (serial number) was updated to reflect the correct serial number of the head section of the bed, which was the part that was returned and evaluated.The original serial number provided was for the foot spring section of the same bed.

Event Description

The head section of the bed had a cracked tube.

• Brand Name: HEAD SPRING SCTN-ALL MDLS 9153638197
• 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: 5443566
• MDR Text Key: 38425798
• Report Number: 1031452-2016-00555
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5310IVC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• 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