MAUDE Adverse Event Report: MERCURY MEDICAL HYPERINFLATION SYSTEM; RESUSCITATOR,MANUAL,NON SELF-INFLATING

Model Number	10-55833
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While performing positive pressure ventilation (ppv) on a newborn, the bag spontaneously detached from the hub on the face mask.The provider had to reattach the bag in order to continue ppv.The newborn eventually developed spontaneous cry and ppv was discontinued.There was no harm to the newborn.

• Brand Name: HYPERINFLATION SYSTEM
• Common Device Name: RESUSCITATOR,MANUAL,NON SELF-INFLATING
• Manufacturer (Section D): MERCURY MEDICAL; 11300 49th st north; clearwater FL 33762
• MDR Report Key: 9024769
• Report Number: 9024769
• Device Sequence Number: 1891350
• Product Code: NHK
• UDI-Device Identifier: 10641043558331
• UDI-Public: (01)10641043558331
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/28/2019
• Report Date (Section F): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10-55833
• Device Catalogue Number: 10-55833
• Device Lot Number: 1807855833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 4
• Date Report Sent to FDA: 08/28/2019