MAUDE Adverse Event Report: PEDICRAFT, INC. ROVER PEDIATRIC STRETCHER CRIB; BED, PEDIATRIC OPEN HOSPITAL

Model Number 22000

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2014

Event Type  No Answer Provided  

Event Description

Hospital reported via an fda form 3500 voluntary report that the child fell from a secured crib and was not injured in any way.It was reported that "the railing lowered despite locking it in place".Pedicraft received this report on (b)(4) 2014.The cover letter provided to pedicraft by the reporter indicated, "please note that the attached is a voluntary report of an equipment-related incident which did not cause or contribute to a death or serious injury".

Manufacturer Narrative

Hospital purchased replacement parts prior to pedicraft receiving the fda form 3500 and intends to replace the appropriate parts and return the product to service.This problem, as reported, could not be duplicated.A picture that was included with the initial voluntary report does show wear on the part pictured, but the latch is locked and would require some upward movement in order for the side rail to unlock and lower.The product involved was put into service in august of 2006.The wear shown in picture that was attached with the initial report would take several years to achieve and would require repeated and frequent use contra indicated by the product's instructions for use.Specifically, labelling instructs raising the side rail without using the handle.Labelling also instructs that preventative maintenance be performed at least once every six months.Given the info we have, this event does not reach the level of any of the reportable event types, but we submit the form fda 3500a in the absence of a voluntary reporting vehicle for mfrs.

• Brand Name: ROVER PEDIATRIC STRETCHER CRIB
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): PEDICRAFT, INC.; jacksonville FL
• Manufacturer Contact: doug maynard ; 4134 st augustine road; jacksonville, FL 32207 ; 9043969627
• MDR Report Key: 4024919
• MDR Text Key: 16446584
• Report Number: 1043568-2014-00001
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22000
• Device Catalogue Number: 22000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 MO