MAUDE Adverse Event Report: CAMTEC RC1000 BED; ELECTRIC PATIENT BED

Model Number RC1000BED

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported to the manufacturer by the end user, per the end user there were no witnesses to the fall, however she states that the rail on the frame is broken.The patient was sent to another facility for a ct scan due to the swelling on the head and the patient has returned to this facility.The bed involved in the incident was picked up and another bed was placed for the patients' use.Numerous requests to this facility have been made to receive additional information and details related to this alleged incident report with no response from the facility.(b)(4) was entered into our system to have the bed returned to joerns for investigation.As of this writing, the bed has not been returned.

• Brand Name: RC1000 BED
• Type of Device: ELECTRIC PATIENT BED
• Manufacturer (Section D): CAMTEC; 1959 church creek rd; cambridge MD 21613
• Manufacturer (Section G): CAMTEC; 1959 church creek rd; cambridge MD 21613
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 5440874
• MDR Text Key: 38313169
• Report Number: 3009402404-2016-00006
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RC1000BED
• Device Catalogue Number: RC1000BED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization