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

Model Number 120003 

Device Problems Break (1069); Medical Gas Supply Problem (2985)

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

Event Type  malfunction  

Event Description

Information was received that a on a smiths medical pneupac parapac ventilator "oxygen does not work, something loose inside." no adverse effects were reported.

Manufacturer Narrative

One ventilator was returned for evaluation.Visual inspection of the device found it to have a broken stand off and damaged piezo on demand detector and osciallator block.The device underwent functional testing by attaching 50 psi to the device; consistent flow was noted, not confirming the first part of the customer's complaint.The second part of the reported complaint was confirmed however through the visual inspection.Furhter functional testing found no alarm light indicator to be on.Replaced alarm led pcb part, resulting in a functioning alarm indicator.The device was noted to have also failed the 60 second shut down; the main alarm board was replaced.The device then passed all functional testing.The problem source has been determined to be user interface.

• Brand Name: PNEUPAC PARAPAC VENTILATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)PRODUCT CODE: BTL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8499877
• MDR Text Key: 141477033
• Report Number: 3012307300-2019-01906
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: 10610586045486
• Combination Product (y/n): N
• PMA/PMN Number: K020899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 120003
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1