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

Catalog Number FL19F

Device Problem Bent (1059)

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

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It was reported that the metal bar that supports the protective top was bent.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the metal bar that supports the protective top was bent.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Upon completion of the manufacturer's investigation it was determined that the bent metal bar that supports the protective top would not impact the primary functioning of the unit.This issue is not likely to cause or contribute to serious injury or death if it was to recur.

• Brand Name: CUB PEDIATRIC CRIB- FIXED 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3767614
• MDR Text Key: 4554309
• Report Number: 0001831750-2014-02928
• 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: Consumer
• 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: FL19F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2014
• 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