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

Catalog Number FL19

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/08/2015

Event Type  malfunction  

Event Description

It was reported that allegedly a child patient was able to get their legs through the opening between the top of the crib and the crib topper and then wedge their body through until they became entrapped.It was reported that no injury or medical intervention resulted from the event.

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 such gap.

Event Description

It was reported that allegedly a child patient was able to get their legs through the opening between the top of the crib and the crib topper and then wedge their body through until they became entrapped.It was reported that no injury or medical intervention resulted from the event.

Manufacturer Narrative

This is a duplicate of mfr report # 0001831750-2015-00261.The serial number (b)(4) and catalog number fl19 reported for this complaint were accidentally submitted into the complaint handling system twice for the exact same complaint instance.Please refer to mfr report # # 0001831750-2015-00261 for full reporting.

Event Description

It was reported that allegedly a child patient was able to get their legs through the opening between the top of the crib and the crib topper and then wedge their body through until they became entrapped.It was reported that no injury or medical intervention resulted from the event.

• 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: 4973003
• MDR Text Key: 23823660
• Report Number: 0001831750-2015-00384
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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?: No
• Date Manufacturer Received: 07/08/2015
• 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