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

Catalog Number FL19

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 05/12/2015

Event Type  malfunction  

Event Description

It was alleged that the patient was found stuck between the canopy and bed.The patient was not harmed during this event.No adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was reported that the patient was unattended at the time that the patient was discovered by the patient¿s mother.It was also reported that the patient did not receive an injury due to the alleged event.A dimensional inspection was performed by a stryker quality technician and subject matter expert stryker r&d sr staff engineer.A visual comparison was conducted between the returned product and a manufacture equivalent unit, which confirmed that the gap between the topper and toprail were similar and the products showed no defects or malfunction.On both units, the team was able to replicate the alleged condition of creating a gap, however; an abnormal force was required in order to create a gap.

Event Description

It was alleged that the patient was found stuck between the canopy and bed.The patient was not harmed during this event.No adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: CUB
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4817558
• MDR Text Key: 15249577
• Report Number: 0001831750-2015-00261
• 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: Health Professional,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

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: FL19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 06/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: No
• 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