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

Catalog Number 4400324000

Device Problem Component Missing (2306)

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

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

The customer performed their own repair.

Event Description

It was reported by service report that the bassinet was missing a caster.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: BASSINET, TRADITIONAL 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5823301
• MDR Text Key: 51227286
• Report Number: 0001831750-2016-00239
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2016

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 Catalogue Number: 4400324000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2013
• 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