MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Model Number 125137

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device's tubing was missing in box.Customer indicated that there was no patient involvement.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 7742268
• MDR Text Key: 115925094
• Report Number: 8020889-2018-00075
• Device Sequence Number: 1
• Product Code: BYE
• UDI-Device Identifier: 10884521620025
• UDI-Public: 10884521620025
• Combination Product (y/n): N
• PMA/PMN Number: K912240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 125137
• Device Catalogue Number: 125137
• Device Lot Number: 201709355X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 10/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1