MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS VR1 AIR MIX; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	520A1300US
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that the pneupac ventilators vr1 air mix failed to stay in auto mode.No death or serious injury was reported in connection with this incident.
Additional Manufacturer Narrative
Device evaluation: a smiths medical, vr1 ventilator was received in good condition.Performed initial check of momentary valve/auto switch.Found that switch would not stay in auto mode position, it would rotate back to manual position.This confirmed customer reported reason.Replaced momentary switch part number 520a1311.Tested to 504-2046.Device passed all functional tests.The customer reported condition was confirmed.Dhr review summary: previous service record is attached and review deemed it as unrelated to this complaint.Allegation confirmed: yes.Problem source details: possible normal wear and tear.

• Brand Name: PNEUPAC VENTILATORS VR1 AIR MIX
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7870904
• Report Number: 3012307300-2018-03551
• Device Sequence Number: 16459648
• Product Code: BTL
• UDI-Device Identifier: 10610586045738
• UDI-Public: 10610586045738
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K051322
• 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,Followup
• Report Date (Section B): 06/27/2019

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 Catalogue Number: 520A1300US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1