MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60 VENT, CHINA OPT: CFLEX, AVAPS

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 11/16/2021

Event Type  Injury  

Event Description

Philips received notification that while in clinical and therapeutic use of a v60 ventilator a patient experienced a pneumothorax.The v60 ventilator in clinical and therapeutic use at the time of the event.Device settings and configuration have not been disclosed to the manufacturer.It was noted that the patient was hospitalized at 2308 on (b)(6) 2021 due to an acute attack of bronchial asthma and acute heart failure.At 0000 on (b)(6) 2021 the patient was prescribed and placed onto non-invasive ventilation (settings and device configuration unspecified).The patient remained on non-invasive positive pressure ventilation for approximately 7 hours and 40 minutes.At approximately 0747 the patient complained of chest tightness with the following vitals: saturation of peripheral oxygenation (spo2) 78% while receiving an unspecified fio2, respiratory rate 28, blood pressure 143 systolic / 84 diastolic.The patient underwent bedside chest x-ray which revealed right lung pneumothorax and lung tissue compression of approximately 50%.The patient was then placed onto high flow oxygen therapy (make, model, settings unspecified) and monitored with bedside ecg monitoring.Bedside closed drainage was performed with 600ml of gas extracted and the patient was connected to a negative pressure drainage bottle for continuous drainage.After treatment, the patient's dyspnea improved with the following vitals noted: spo2 97%, respiratory rate 21, blood pressure 127 systolic / 73 diastolic.No allegation of device malfunction or failure to perform to manufacturer declared specifications has been noted.No device evaluation has been noted within the complaint record.

Manufacturer Narrative

Reporter phone# (b)(6).

Manufacturer Narrative

The patient's spo2 at the time of event resolution was 97%.The customer confirmed that there was no direct allegation that the device may have caused or contributed to the patient injury.Philips is unable to establish a conclusion, and root cause as the status of device evaluation and resultant findings were requested but remained unknown.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 13102678
• MDR Text Key: 282915544
• Report Number: 2031642-2021-05896
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: V60 VENT, CHINA OPT: CFLEX, AVAPS
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/23/2022
• 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): Required Intervention