MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS QS820 MANUAL BED; BED, MANUAL

Model Number IH820

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reporter stated damaged head board.Update - reporter advised that head deck on bed was bent.

• Brand Name: QS820 MANUAL BED
• Type of Device: BED, MANUAL
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5060240
• MDR Text Key: 25816009
• Report Number: 1031452-2015-15852
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• 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