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

Catalog Number 4402000001

Device Problem Inflation Problem (1310)

Patient Problem No Code Available (3191)

Event Date 05/24/2018

Event Type  malfunction  

Event Description

It was reported that the bassinet mattress had overinflated due to being in the high altitude.The customer received 9 bassinets and all mattresses experienced the overinflation issue.Additionally, there were reports that the overinflated mattresses had caused infants to roll to the sides of the bassinet.No adverse consequence was reported.

Manufacturer Narrative

Stryker medical notified fda of field action (b)(4) on (b)(4) 2018.

Event Description

It was reported that the bassinet mattress had overinflated due to being in the high altitude.The customer received 9 bassinets and all mattresses experienced the overinflation issue.Additionally, there were reports that the overinflated mattresses had caused infants to roll to the sides of the bassinet.No adverse consequence was reported.

• Brand Name: NARA, DOMESTIC
• Type of Device: 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7609605
• MDR Text Key: 111836242
• Report Number: 0001831750-2018-00588
• Device Sequence Number: 1
• Product Code: NZG
• UDI-Device Identifier: 07613327261615
• UDI-Public: 07613327261615
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4402000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: PR 1814402
• Patient Sequence Number: 1