MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. PARAPAC VENTILATOR; BTL-VENTILATOR, EMERGENCY, POWERED ( RESUCITATOR)

Catalog Number 120003V

Device Problem No Flow (2991)

Patient Problem Respiratory Distress (2045)

Event Date 06/07/2015

Event Type  Injury  

Event Description

A report was received stating that the listed device was in use on a patient when the device stopped functioning.Reporter stated, "the patient was subsequently revived." multiple requests for further information have been asked of user facility, but not provided date.

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Manufacturer Narrative

One used mechanical ventilation system was returned for inspection.Visual inspection observed the front panel and alarm bezel had some divets, dings, and cracks.During functional testing, a device issue other than what was reported, was noted.The non-return valve (connected to the oscillator) was found leaking when a spontaneous breath was taken.Despite the leak during spontaneous breaths, the device was confirmed to cycle and function at all settings.It is recommended to have the mechanical ventilation system serviced annually for maintance.Service and repair documentation revealed that the device had not been serviced for 4 years.The alarm bezel, front panel and non-return valve were repaired.

• Brand Name: PARAPAC VENTILATOR
• Type of Device: BTL-VENTILATOR, EMERGENCY, POWERED ( RESUCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; luton ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.,; bramingham business park; enterprise way; luton, beds, LU3 4BU; UK LU3 4BU
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4895147
• MDR Text Key: 6830051
• Report Number: 2183502-2015-00467
• Device Sequence Number: 1
• Product Code: BTL
• 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: Unknown
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 120003V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2015
• Distributor Facility Aware Date: 06/07/2015
• Device Age: 121 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2005
• 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
• Patient Outcome(s): Required Intervention