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

Catalog Number 530A1167NPL

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

One ventilator was returned for evaluation.Upon powering on the device, it did not cycle.This confirms the reported customer complaint.To investigate the possible causes of the failure the device was removed from its case.The needle locked off in the seat had caused the reported fault.However, the problem source is not known as this device passed all manufacturing tests.

Event Description

Information was received that during pre-test, the manometer is switched on upon power up.The oxygen indicator had worked just fine, but device did not provide oxygen.No alarm occurred, and no patient involvement.

• Brand Name: PARAPAC
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 10461393
• MDR Text Key: 204599568
• Report Number: 3012307300-2020-08394
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 08/27/2020

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
• Device Operator: No Information
• Device Catalogue Number: 530A1167NPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1