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

Catalog Number FL19

Device Problem Positioning Failure (1158)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the siderail had a false latch.  there was no patient involvement.

Event Description

This report summarizes 1 malfunction event, where it was reported the siderail had a false latch.  there was no patient involvement.

Manufacturer Narrative

The device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.H3 other text : see h11.

• Brand Name: CUB
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 10005193
• MDR Text Key: 189235713
• Report Number: 0001831750-2020-00562
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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: FL19
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1