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 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.13 devices were evaluated in the field and the issue was confirmed; 7 units had broken/damaged components, 3 had worn components, 2 had detached components, 1 had a misaligned component.The devices were repaired and returned.2 devices were not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 17 malfunction events, where it was reported the access door or siderail would not latch or dropped quickly when lowering.15 events had no patient involvement.2 events had patient involvement, however there were no consequences or impacts to the patient.

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.13 devices were evaluated in the field and the issue was confirmed; 7 units had broken/damaged components, 3 had worn components, 2 had detached components, 1 had a misaligned component.The devices were repaired and returned.2 devices were not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support.The remaining devices were evaluated, and the issue was confirmed; both devices had mechanical problems.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 17 malfunction events, where it was reported the access door or siderail would not latch or dropped quickly when lowering.15 events had no patient involvement.2 events had patient involvement, however there were no consequences or impacts to the patient.

• 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: 8836077
• MDR Text Key: 152517583
• Report Number: 0001831750-2019-00812
• 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: 17
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2019
• 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