MAUDE Adverse Event Report: HARD MANUFACTURING COMPANY INC. PEDIATRIC CRIB; BED, PEDIATRIC OPEN HOSPITAL

Model Number C1943

Device Problems Component Falling (1105); Device Slipped (1584)

Patient Problem Fall (1848)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

Toddler was standing up in the crib hanging on to side-rail when the crib rail fell allowing child to fall from crib.Crib rail was at the highest position.Nursing student thought the side-rail had latched.Student and mother and visitor in the room when the rail fell.When crib checked by maintenance it was thought that the latch on the side-rail wasn't completely engaged.

• Brand Name: PEDIATRIC CRIB
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): HARD MANUFACTURING COMPANY INC.; 230 grider street; buffalo NY 14215
• MDR Report Key: 3842640
• MDR Text Key: 17986988
• Report Number: 3842640
• Device Sequence Number: 1
• Product Code: FMS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/16/2014

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: Invalid Data
• Device Model Number: C1943
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2014
• Device Age: 20 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2014
• Patient Sequence Number: 1
• Patient Age: 11 MO
• Patient Weight: 10