MAUDE Adverse Event Report: ST PAUL PNEUPAC VR1 AIR MIX; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	VR1AIRNJ
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cyanosis (1798)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other text: g5: no 510k as product not sold in us.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a patient went into cardiopulmonary arrest during use."previously used vr1 when taking a bath".When a ct scan was performed, the patients face turned brown and cyanosis was confirmed, and went into cardiopulmonary arrest.The patient was immediately resuscitated by administering cardiac massage and electric shock, and returned to the ward and put on a ventilator.Then at 11:30 the patient had the same symptoms again.The second time, the patient was not using vr1, so the reporter believes it to be an issue with the patient.The patient's condition has since stabilized.Adverse patient effects are unknown.
Additional Manufacturer Narrative
Device evaluation: one device was received.A visual inspection found that the noairmix/airmix switching lever was about to break.During the functional testing, it was found that there was no abnormality other than the switching lever being about to break.The cause of the reported event was not found to be caused by this product.The air mix switch was replaced.Product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.
Additional Manufacturer Narrative
D4: udi updated.Udi related data quality updates only.

• Brand Name: PNEUPAC VR1 AIR MIX
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 18144061
• Report Number: 3012307300-2023-10519
• Device Sequence Number: 7609118
• Product Code: BTL
• UDI-Device Identifier: 35019315074862
• UDI-Public: (01)35019315074862(11)190313
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: VR1AIRNJ
• Device Catalogue Number: VR1AIRNJJP
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/29/2023; Not provided
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 06/26/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown