MAUDE Adverse Event Report: FLEXTRONICS CS3 BED 9153651161; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHCS7

Device Problem Device Slipped (1584)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record wil be filed.

Event Description

Customer states he received this bed and brake mechanism not working.This is the foot end brake and it does not stop the bed like it is supposed to.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the bed frame brakes will not lock, which confirmed the original complaint issue.However, the underlying cause could not be determined.

Event Description

Customer states he received this bed and brake mechanism not working.This is the foot end brake and it does not stop the bed like it is supposed to.

• Brand Name: CS3 BED 9153651161
• 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: 5297199
• MDR Text Key: 34119972
• Report Number: 1525712-2015-05730
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• 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