MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CUB PEDIATRIC CRIB- HYD BASE; BED, PEDIATRIC OPEN HOSPITAL

Catalog Number FL19H

Device Problems Device Slipped (1584); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2017

Event Type  malfunction  

Event Description

It was reported that the siderail won't latch due to a worn siderail assembly.No patient involvement and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was found that the siderail would not latch/lock in the middle position and this was due to a broken/damaged latching assembly as well as a broken/damaged column.

Event Description

It was reported that the siderail won't latch due to a worn siderail assembly.No patient involvement and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: CUB PEDIATRIC CRIB- HYD BASE
• 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: 6869503
• MDR Text Key: 86737336
• Report Number: 0001831750-2017-00403
• 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,Followup
• Report Date: 10/06/2017

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: FL19H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 10/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2011
• 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