MAUDE Adverse Event Report: SMITHS MEDICAL PNEUPAC; VENTILATOR, EMERGENCY

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2018

Event Type  Injury  

Event Description

Pneupac vl1 "portable ventilator" lacks any alert/alarm to notify staff when oxygen flow ends.As this unit does not provide any type of room air bleed - in, once the oxygen source is depleted, no further breaths are delivered and no alarm to staff.

• Brand Name: PNEUPAC
• Type of Device: VENTILATOR, EMERGENCY
• Manufacturer (Section D): SMITHS MEDICAL; minneapolis MN
• MDR Report Key: 7323097
• MDR Text Key: 101973969
• Report Number: MW5075740
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR
• Patient Weight: 136