MAUDE Adverse Event Report: STRYKER MEDICAL BASSINET; BASSINET, HOSPITAL

Device Problems Detachment Of Device Component (1104); Material Disintegration (1177); Device Tipped Over (2589)

Patient Problem Pain (1994)

Event Date 09/29/2016

Event Type  malfunction  

Event Description

A newborn infant was placed in the stryker bassinet.The bassinet was being pushed down the hallway by the nurse.The bassinet wheel abruptly fell off the bassinet- it appears that part of the wood which attached the wheel to the bassinet framework suddenly seemed to disintegrate and the wood with the attached wheel "fell off" the frame- this sudden shift in balance caused the bassinet to tip over.The nurse caught the infant before it could fall out of the bassinet.The infant was not harmed.The employee suffered some pain when the weight of the crib itself landed on the nurse's foot.

• Brand Name: BASSINET
• Type of Device: BASSINET, HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 6442382
• MDR Text Key: 71138543
• Report Number: 6442382
• Device Sequence Number: 1
• Product Code: NZG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO