MAUDE Adverse Event Report: FLEXTRONICS CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHCS7

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer alleged the brake assembly is faulty and will not engage.

Manufacturer Narrative

A follow up will be sent if the product or additional information is obtained.

• Brand Name: CS BED 9153650455
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): FLEXTRONICS; boulevard a zacatecas km 9.5; jesus maria, aquascalientes; 20900 mexico, c.p. ; MX
• Manufacturer (Section G): FLEXTRONICS; boulevard a zacatecas km 9.5; jesus maria, aquascalientes; 20900 mexico, c.p. ; MX
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4886770
• MDR Text Key: 6044371
• Report Number: 1525712-2015-03681
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHCS7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other