MAUDE Adverse Event Report: PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	130002V
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Tidal Volume Fluctuations (1634); Failure to Align (2522)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical pneupac accessory transport ventilator gave high tidal volume readings on the lower end.There were no reported adverse effects.
Additional Manufacturer Narrative
Other, other text: one transport vent was returned for analysis.Upon visual inspection, the knobs were found to be in the incorrect placement; there was a large knob on the relief pressure spindle and the incorrect end cap on the air mix knob.Knobs also were observed to not align with the calibration marks.The gauge retainer was found torn, the patient outlet connector was loose, the outlet connector was missing a component, and the housing contains minor wear.Oxygen supply was connected to the unit and testing performed; confirming the complaint as the tidal volume measured high at 244mls at the low setting.Based on the evidence, the root cause was found to be due to user interface as the knobs were misaligned and not calibrated.

• Brand Name: PNEUPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 10270516
• Report Number: 3012307300-2020-07258
• Device Sequence Number: 825253
• Product Code: BTL
• UDI-Device Identifier: 10610586045622
• UDI-Public: 10610586045622
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K030803
• 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): 08/17/2020

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: 130002V
• Device Catalogue Number: 130002V
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1