MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PNEUPAC VR1 EMERGENCY VENTILATOR/RESUSCITATOR; BTL - VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number VR1AIRNJ

Device Problem No Flow (2991)

Patient Problem Death (1802)

Event Type  Death  

Event Description

A report was received stating that the listed device was in use on a patient when the device stopped functioning.The patient was then manually ventilated using an ambu bag.The report states that two days later, the patient expired due to cardiopulmonary arrest.The user facility is unsure of any relation between cessation of ventilator and the patient's expiration two days later.

Manufacturer Narrative

Device evaluation: the suspect device was returned to our service center in (b)(4).Functional testing performed by the technical service personnel found the device to operate as specified.No devices issues were found.The device was returned to the customer and is presumed to have been placed back into service.This information was entered into the manufacturer's complaint database for tracking and reporting purposes.

• Brand Name: PNEUPAC VR1 EMERGENCY VENTILATOR/RESUSCITATOR
• Type of Device: BTL - VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; luton ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; bramingham business park; enterprise way; luton, beds LU3 4BU; UK LU3 4BU
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4274170
• MDR Text Key: 5296422
• Report Number: 2183502-2014-00871
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/14/2014

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: VR1AIRNJ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2014
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 11/17/2014
• Date Device Manufactured: 02/01/2014
• 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): Death