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

Model Number IHCS7

Device Problems Cut In Material (2454); Device Unsafe to Use in Environment (2918)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer alleged the zip ties that came on the bed were to tight and cut into the cord exposing the wires on the power cord.

• 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: 5359630
• MDR Text Key: 35617628
• Report Number: 1525712-2016-00061
• 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
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• 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: 12/21/2015
• 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