MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PNEUPAC® PARAPAC® VENTILATOR; VENTILATOR, EMERGENCY, POWERED

Catalog Number 120003

Device Problem Medical Gas Supply Problem (2985)

Patient Problem Hypoventilation (1916)

Event Type  Injury  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

User facility reported that during use of the device for patient ventilation, the device stopped functioning after about 30 minutes in use.According to reporter, the oxygen supply attached to the ventilator ran out of oxygen and the patient required resuscitation.There were no permanent adverse effects to patient reported.

Manufacturer Narrative

The reported device was returned for product evaluation.The device was received with the battery fitted and an input hose; however, the hose was not manufactured by smiths medical.Visual inspection of the device found the device to have impact damage and a loose output connector.During investigation, the subassemblies were removed and individually inspected for damage, contamination, or debris; no fault was found.During functional testing, the device was powered on and was set to cycle; the device cycled throughout testing and investigation.The device correctly provided visual and audible alarms when the oxygen supply was low/disconnected.Per the user manual, the low pressure/disconnect led and medium priority alarm activated and the gas supply indicator turned red.The device operated as intended and no fault was found related to the reported issue.

• Brand Name: PNEUPAC® PARAPAC® VENTILATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; bramingham business park; enterprise way; luton, beds LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LIMITED; bramingham business park enter; enterprise way; luton, herts LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5658111
• MDR Text Key: 45275537
• Report Number: 2183502-2016-00954
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention