MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BASSINET, SHAKER STYLE; BED, PEDIATRIC OPEN HOSPITAL

Catalog Number 4400224000

Device Problem Structural Problem (2506)

Patient Problem No Information (3190)

Event Date 04/27/2017

Event Type  malfunction  

Event Description

It was reported that the bassinet tub was not structurally sound due to being broken.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The issue was resolved for the customer by replacing the tub.

Event Description

It was reported that the bassinet tub was not structurally sound due to being broken.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: BASSINET, SHAKER STYLE
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6591233
• MDR Text Key: 76076138
• Report Number: 0001831750-2017-00206
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

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 Catalogue Number: 4400224000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1