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

Catalog Number FL19H

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed; 3 devices had missing components, 3 devices had alignment issues, and 14 devices had broken/damaged components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 21 malfunction event(s), where it was reported the door or siderail wouldn't latch/lock.There was no patient involvement.

• Brand Name: CUB PEDIATRIC CRIB- HYD BASE
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 9239621
• MDR Text Key: 166521788
• Report Number: 0001831750-2019-01181
• Device Sequence Number: 1
• Product Code: FMS
• UDI-Device Identifier: 07613327169348
• UDI-Public: 07613327169348
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 21
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

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: FL19H
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/25/2019
• 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