MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PNEUPAC¿ PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	100/905/340
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that during ventilation of a patient with a smiths medical pneupac¿ parapac plus, a constant low pressure alarm sounded.The gauge on the ventilator was reported to show normal ventilation pressure.It was noted that it was thought to have been caused by a loose cap on top of the one way valve of the ventilator circuit.There were no reported adverse patient effects.

• Brand Name: PNEUPAC¿ PARAPAC PLUS
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7944614
• Report Number: 3012307300-2018-03958
• Device Sequence Number: 16357985
• Product Code: BTL
• UDI-Device Identifier: 15019315076107
• UDI-Public: 15019315076107
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: Health Professional
• Device Expiration Date: 01/24/2020
• Device Catalogue Number: 100/905/340
• Device Lot Number: 170124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1