MAUDE Adverse Event Report: STRYKER NUMBER 4400-118-106; BED, PEDIATRIC

Model Number NUMBER 4400-118-106

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Plastic bassinet tubs / cribs, the corners are cracking not due to abuse.

• Brand Name: NUMBER 4400-118-106
• Type of Device: BED, PEDIATRIC
• Manufacturer (Section D): STRYKER
• MDR Report Key: 5445273
• MDR Text Key: 38527371
• Report Number: MW5060276
• Device Sequence Number: 1
• Product Code: FMS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2016

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: No Information
• Device Model Number: NUMBER 4400-118-106
• Other Device ID Number: NUMBER 4400-118-106
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1