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

Model Number B100

Device Problems Loss of Power (1475); No Flow (2991); No Pressure (2994)

Patient Problem Hypoventilation (1916)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient was a baby; however, the exact age is unknown.Customer has not returned the device to the manufacturer for device evaluation.If the devices becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a pneupac® babypac¿ ventilator stopped working while in use on an airplane.The ventilator was connected on an oxygen cylinder that was full and connected to the airplane gas line.When the plane landed, there was a power loss, and no o2 was flowing through the device.Once the power returned, the ventilator did not work until the oxygen was disconnected and reconnected.The patient was manually ventilated.No permanent injury was reported.See mfr: 3012307300-2017-00948 and 3012307300-2017-00950.

Manufacturer Narrative

One device was returned for evaluation in used condition.Visual inspection of the ventilator did not identify any problem.It was observed that an old design exhalation valve was installed.Functional testing involved a simulated use test and showed that the reported issue was duplicated when input pressure was slowly increased.A leaking sound could be heard when the oxygen valve was slowly opened.It was identified that the oscillator dump valve was loose and the dump valve surface was rusted.Based on the evidence, it was shown that there was a pressure issue and the root cause was unknown.

• Brand Name: PNEUPAC® BABYPAC¿ VENTILATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; bramingham business park; enterprise way; luton, LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 6526775
• MDR Text Key: 73850202
• Report Number: 3012307300-2017-00949
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: B100
• Device Catalogue Number: 510A1960NCA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 06/20/2017
• Supplement Dates FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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): Required Intervention