MAUDE Adverse Event Report: NOVUM MEDICAL PRODUCTS INC NK MEDICAL CRIB; BED, PEDIATRIC OPEN HOSPITAL

Model Number 17798

Device Problems Unintended System Motion (1430); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2020

Event Type  malfunction  

Event Description

Patient sitting in crib when front side rail fell down.Mother was nearby and patient was not harm.Mother immediately put railing back up, but crib handle came off.Once the handle broke off, we were unable to lower the crib railing with the patient still in the crib.Crib has been removed from patient room and new crib ordered.

• Brand Name: NK MEDICAL CRIB
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): NOVUM MEDICAL PRODUCTS INC; 80 creekside drive p.o. box 627; amherst NY 14228
• MDR Report Key: 9595670
• MDR Text Key: 175219873
• Report Number: 9595670
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2020

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: Other
• Device Model Number: 17798
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 660 DA
• Patient Weight: 12