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

Model Number ICHS7

Device Problems Collapse (1099); Unintended Head Motion (1284)

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

Event Type  malfunction  

Event Description

(b)(6) 2015 - per (b)(6) pediatric center alleged while the bed was in a room with a patient in it, the head section was in a raised position and collapsed.She also states she is not aware if anyone was in the room when this occurred.Serial (b)(4) bed.She asked if she could call back tomorrow and provide more information.No further information was provided.

Manufacturer Narrative

Additional information will be added as it becomes available.

• Brand Name: CS BED 9153650455
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1P5; CA N6E 1P5
• Manufacturer Contact: kevin guyton ; 1200 taylor street; elyria, OH 44036
• MDR Report Key: 4815179
• MDR Text Key: 17208688
• Report Number: 3003433498-2015-00074
• 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
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ICHS7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 06/03/2015
• 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