MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO NARA, DOMESTIC; BASSINET, HOSPITAL

Catalog Number	4402000001
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.3 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 3 malfunction events, where it was reported the devices experienced mattress is too soft; too much mattress immersion.There was no patient involvement.
Event or Problem Description
This report summarizes 0 malfunction events, where it was reported the devices experienced mattress is too soft; too much mattress immersion.There was no patient involvement.
Additional Manufacturer Narrative
For the 3 devices that were pending, it was reported that the customer was dissatisfied with the nara mattress as designed and felt it was too soft.Per 21 cfr 820 this does not meet the definition of a complaint as there was no malfunction of a medical device, adverse event, or patient involvement.Therefore, no regulatory reporting is required.Section h codes have been updated.

• Brand Name: NARA, DOMESTIC
• Common Device Name: BASSINET, 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19850109
• Report Number: 0001831750-2024-01025
• Device Sequence Number: 6813542
• Product Code: NZG
• UDI-Device Identifier: 07613327261615
• UDI-Public: 07613327261615
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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 Catalogue Number: 4402000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown