MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS BED EXTENDER 9153650579; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5310IVC

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dealer states two components were being used in conjunction, a head section from 2014 and a foot section from 2015, and that they delivered it to a customer who called them later and stated that the bed felt uneven.He states they went out and replaced the bed and when they brought it back into the shop it looks like the frame might be spent or "sprung" as he called it.

Manufacturer Narrative

The device was evaluated where they found the drive arm to be bent.

Event Description

Dealer states two components were being used in conjunction, a head section from 2014 and a foot section from 2015, and that they delivered it to a customer who called them later and stated that the bed felt uneven.He states they went out and replaced the bed and when they brought it back into the shop it looks like the frame might be spent or "sprung" as he called it.

• Brand Name: BED EXTENDER 9153650579
• 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: 5097309
• MDR Text Key: 26733230
• Report Number: 1031452-2015-16063
• 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: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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: 09/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• 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