MAUDE Adverse Event Report: HARD BED, PEDIATRIC OPEN HOSPITAL

Device Problem Collapse (1099)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the original equipment manufacturer of the reported device.The customer alleged a hard crib, serial number unknown, isolation canopy collapsed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, PEDIATRIC OPEN HOSPITAL
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): HARD
• MDR Report Key: 17527832
• MDR Text Key: 321384853
• Report Number: MW5134763
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1