MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC DISPOSABLE SINGLE LIMB CIRCUIT FOR PNEUPAC DEMAND VENTILATORS ; CIRCULATOR, BREATHING-CIRCUIT

Catalog Number 100/905/300

Device Problem Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign report source: (b)(6).

Event Description

Information was received that an abnormal noise was heard from a smiths medical pneupac disposable single limb circuit for pneupac demand ventilators while in use with a ventilator.There were no adverse patient effects.

Manufacturer Narrative

Corrected information: the file was inadvertently marked reportable.The event reported under mfr 3012307300-2019-04991-0040004 was determined to be not reportable and no further reports will be filed using this file number.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.

• Brand Name: PNEUPAC DISPOSABLE SINGLE LIMB CIRCUIT FOR PNEUPAC DEMAND VENTILATORS
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9090331
• MDR Text Key: 159370553
• Report Number: 3012307300-2019-04991
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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
• Device Operator: No Information
• Device Catalogue Number: 100/905/300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 05/27/2019
• Supplement Dates FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMITHS MEDICAL PNEUPAC DEMAND VENTILATOR