PLV CONTINUUM II VENTILATOR

Report

• Report Number: 2031642-2011-00363
• Event Type: Malfunction
• Date Received: October 17, 2011
• Date of Event: September 12, 2010
• Report Date: September 19, 2011
• Manufacturer: RESPIRONICS CALIFORNIA, INC.
• Product Code: CBK
• PMA / PMN Number: K034032
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: CA, US
• Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL PRODUCT CODE: NOU.

Description of Event or Problem · 1

DURING EVALUATION OF THE DEVICE UPON RETURN FROM THE CUSTOMER, REVIEW OF THE VENTILATOR EVENT LOG NOTED A VENT INOP OCCURRENCE DUE TO A ADC WRAPAROUND FAILURE. THE VENT INOP OCCURRENCE WAS NOT REPORTED BY THE CUSTOMER, AND THERE WAS NO PATIENT HARM REPORTED. THE VENT INOP INDICATOR SIGNALS THE OPERATOR THAT THE VENTILATOR IS NOT CAPABLE OF SUPPORTING VENTILATION AND REQUIRES SERVICE. THE MAIN PCB BOARD WILL BE REPLACED DURING COMPLETION OF SERVICE TO ADDRESS THE FINDING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PLV CONTINUUM II VENTILATOR	VENTILATOR, CONTINUOUS	CBK	RESPIRONICS CALIFORNIA, INC.	P2000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Patient Involvement

Product problems · 1

• Device Inoperable

Source type · 1

• Other

Type of report · 1

• Initial submission