MAUDE Adverse Event Report: PEDIATRIC 1ST RESPONSE MANUAL RESUSCITATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number	8520BMP
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was found to leak and would not hold pressure.No adverse effects reported.

• Brand Name: PEDIATRIC 1ST RESPONSE MANUAL RESUSCITATOR
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• MDR Report Key: 11820120
• Report Number: 3012307300-2021-04297
• Device Sequence Number: 17074634
• Product Code: BTM
• UDI-Device Identifier: 15019517101119
• UDI-Public: 15019517101119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K014115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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
• Operator of Device: No Information
• Device Model Number: 8520BMP
• Device Catalogue Number: 8520BMP
• Device Lot Number: 181114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1