MAUDE Adverse Event Report: PEDICRAFT, INC. PEDICRAFT BASSINET; BASSINET, HOSPITAL

Model Number 01823

Device Problems Break (1069); Crack (1135)

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

Event Date 12/06/2016

Event Type  malfunction  

Event Description

Acrylic bassinets are cracking in the corners creating harm to employees and potential harm to infant.Manufacturer response for acrylic bassinet basket, (brand not provided) (per site reporter): pedicraft vendor was contacted and informed of multiple examples of cracked/broken corners on the baskets creating harm to employee and potential harm to patients.Vendor recommended change in cleaning product.All bassinets inspected and removed from service if cracked.

• Brand Name: PEDICRAFT BASSINET
• Type of Device: BASSINET, HOSPITAL
• Manufacturer (Section D): PEDICRAFT, INC.; 4134 st. augustine rd.; p.o. box 5969; jacksonville FL 32247
• MDR Report Key: 6360144
• MDR Text Key: 68372383
• Report Number: 6360144
• Device Sequence Number: 1
• Product Code: NZG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2017,02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01823
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1