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

Model Number UNKNOWN

Device Problems Detachment Of Device Component (1104); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6) advised mother was laying in the bed and bed made a loud noise and went flat and plastic black pieces came from under the bed.

• Brand Name: CS BED 9153650455
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5349966
• MDR Text Key: 35629224
• Report Number: 1525712-2016-00037
• 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: Patient
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• 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