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

Catalog Number 120003

Device Problem No Flow (2991)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical pneupac® parapac® ventilator was reported not move into ventilation mode.There were no reported adverse effects.

• Brand Name: PNEUPAC® PARAPAC® VENTILATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; bramingham business park; enterprise way; luton, LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 8672440
• MDR Text Key: 147174884
• Report Number: 3012307300-2019-03251
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: 10610586045486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2019

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: 120003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1