MAUDE Adverse Event Report: PEDICRAFT, INC. PEDICRAFT; BASSINET, HOSPITAL

Device Problem Device Slipped (1584)

Patient Problem Fall (1848)

Event Date 01/19/2020

Event Type  malfunction  

Event Description

Patient was in the room with her parents.The left side of the crib rail was down where parents were standing next to the patient, and the right side of the crib was up and locked in place.Per parents', patient was holding on to the crib rails on the right side, the crib rail unlocked and dropped to the next level.Patient flipped over the rail and fell on the floor.

• Brand Name: PEDICRAFT
• Type of Device: BASSINET, HOSPITAL
• Manufacturer (Section D): PEDICRAFT, INC.; 4134 st. augustine rd.; p.o. box 5969; jacksonville FL 32247
• MDR Report Key: 9823668
• MDR Text Key: 183109633
• Report Number: 9823668
• Device Sequence Number: 1
• Product Code: NZG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA