HT70 VENTILATOR

MDR report key: 3261130 · Received July 31, 2013

Report

Report Number: 2023050-2013-00534
Event Type: Injury
Date Received: July 31, 2013
Date of Event: July 19, 2013
Report Date: July 19, 2013
Manufacturer: NEWPORT MEDICAL INSTRUMENTS, INC.
Product Code: CBK
PMA / PMN Number: K090888
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

REPORTEDLY, DURING PATIENT USE, THE PATIENT'S CARE GIVER WAS UNABLE TO CLEAR THE CHECK CIRCUIT ALARM THAT OCCURRED WHILE SUCTIONING, FOR EVERY 5-10 SECONDS. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO SERIOUS OR NEGATIVE PATIENT HEALTH CONSEQUENCES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
358276	HT70 VENTILATOR	CBK, NOU	CBK	NEWPORT MEDICAL INSTRUMENTS, INC.	HT70M

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention