MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the ventilator is giving a high tidal volume while in use on patient.The customer reported that the unit was in use on patient, but there was no patient harm.

Manufacturer Narrative

The biomed was able to confirm the reported problem but no error code was generated.The gds was replaced and the device functioned per manufacture¿s specifications.The customer would not provide patient information.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: betty harris ; 2271 cosmos court; carlsbad, CA 92011
• MDR Report Key: 5148255
• MDR Text Key: 28647006
• Report Number: 2031642-2015-02074
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2013
• 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