MAUDE Adverse Event Report: CARROLL HEALTHCARE BED EXTENDER 9153650579; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number BH2100-00G

Device Problems Device Inoperable (1663); Defective Component (2292); Component Missing (2306)

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

Troubleshooting/assessment: upon investigation, the technician found that the brakes were inoperative and unable to set at the foot end of the bed due to a missing roll pin on the pedal and brakes were unable to hold due to the steer casters being defective.Repair/retest: to resolve the issue, the technician replaced the roll pin on the pedal, replaced the steer casters and adjusted the brakes and performed a functional test per the service manual and the bed functioned as designed.

• Brand Name: BED EXTENDER 9153650579
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1 P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1 P5; CA N6E 1P5
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5928363
• MDR Text Key: 53922456
• Report Number: 3003433498-2016-00256
• 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
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BH2100-00G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2016
• 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