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

Catalog Number FL19H

Device Problems Disconnection (1171); False Reading From Device Non-Compliance (1228)

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

Event Date 02/21/2014

Event Type  malfunction  

Event Description

It was reported that the cable that runs between angle sensor and scale assembly disconnected from the scale.This could potentially give an inaccurate scale reading.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the cable that runs between angle sensor and scale assembly disconnected from the scale.This could potentially give an inaccurate scale reading.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was confirmed by a stryker quality assurance engineer and a senior manufacturing engineer that when the cable that runs between angle sensor and the scale assembly is disconnected the scale reads an (e10) error code and the scale is then inoperable and will not provide a reading.

• Brand Name: CUB PEDIATRIC CRIB- HYD BASE
• Type of Device: PEDIATRIC OPEN HOSPITAL BED
• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3763607
• MDR Text Key: 4418476
• Report Number: 0001831750-2014-02927
• 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: 03/28/2014

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: Other
• Device Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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