MAUDE Adverse Event Report: INVACARE TAYLOR STREET RMA-MATTRESSES/BEDDING/OVERBED TABLES; BED, AC-POWERED ADJUSTABLE HOSPITAL FNL

Model Number NA:BEDPRD

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The bed model number and serial number were not provided.It was reported that the 6629-bed rails would not stay up.Multiple attempts have been made for additional information regarding the alleged complaint; it is not known if the rails were on an invacare bed or not.Return of device for evaluation is not anticipated at this time.Should additional information become available, this record will be updated accordingly.

Event Description

The 6629-bed rail he has, will not stay locked.

• Brand Name: RMA-MATTRESSES/BEDDING/OVERBED TABLES
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL FNL
• Manufacturer (Section D): INVACARE TAYLOR STREET; one invacare way; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; one invacare way; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6412615
• MDR Text Key: 70424474
• Report Number: 1531186-2017-00003
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:BEDPRD
• Date Manufacturer Received: 03/17/2017
• 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