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

Catalog Number 0190000000

Device Problems Difficult or Delayed Positioning (1157); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Event Description

It was reported that the tension rope had snapped, potentially indicating side/endrail collapse.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

Upon evaluation by a stryker technician, it was identified that the side/endrail was difficult to raise/lower.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Upon evaluation by a stryker technician it was identified that the side/endrail was difficult to raise/lower.

• Brand Name: CUB PEDIATRIC CRIB STRETCHER
• Type of Device: BED, PEDIATRIC, OPEN HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11333889
• MDR Text Key: 232065181
• Report Number: 0001831750-2021-00630
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

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: 0190000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1