MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CLEAR CHART HOLDER; BED, PEDIATRIC OPEN HOSPITAL

Catalog Number 4400118231

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 04/28/2014

Event Type  malfunction  

Event Description

It was reported by the customer as a general complaint that the plastic chart holders on some bassinets would often break and have sharp edges.No additional information was available and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported by the customer as a general complaint that the plastic chart holders on some bassinets would often break and have sharp edges.No additional information was available and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Follow-up submitted to report that this was a general complaint and the customer was seeking a chart holder with an alternate material (such as wood).However, it was determined there is no wooden chart holder option available for this model bassinet.Other options will be researched.Customer performed evaluation.

• Brand Name: CLEAR CHART HOLDER
• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3822753
• MDR Text Key: 4391042
• Report Number: 0001831750-2014-03003
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2014

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: Other
• Device Catalogue Number: 4400118231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: No
• 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