MAUDE Adverse Event Report: VYAIRE MEDICAL, INC INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, NON-CONTINUOUS

Model Number SIPAP ABDOMINAL TRANSDUCER

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

Vyaire medical complaint number (b)(4).At this time, vyaire medical has not received the suspect device/component from the customer for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported that the sipap abdominal sensor was in use on a patient and the patient developed a skin burn.The sensor was in place for five days continuously without being changed.Reportedly, the customer had been reluctant to change the sensor due to it getting loosened after washing/cleaning the patient's skin.The patient is no longer on the sipap ventilator.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6909197
• MDR Text Key: 87974317
• Report Number: 2021710-2017-06739
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: SIPAP ABDOMINAL TRANSDUCER
• Device Catalogue Number: 467349
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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