MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PNEUPAC ACCESSORIES; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	122002
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Hypoventilation (1916)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient was placed on an mri ventilator and, the ventilator started peak pressuring right away.The operator attempted to troubleshoot the ventilator but could not find the source of the high pressure.It was further reported that the patient was returned to the room and ventilated with an amu bag.The patient was monitored using a transport monitor.Information pertaining to the current health status of the patient, or if the issue was ongoing or resolved, was unknown.
Event or Problem Description
It was reported that the patient was placed on an mri ventilator and, the ventilator started peak pressuring right away.The operator attempted to troubleshoot the ventilator but could not find the source of the high pressure.It was further reported that the patient was returned to the room and ventilated with an amu bag.The patient was monitored using a transport monitor.Information pertaining to the current health status of the patient, or if the issue was ongoing or resolved, was unknown.

• Brand Name: PNEUPAC ACCESSORIES
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9392897
• Report Number: 3012307300-2019-06639
• Device Sequence Number: 3096410
• Product Code: BTL
• UDI-Device Identifier: 10610586046056
• UDI-Public: 10610586046056
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• 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): 12/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 122002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 12/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention