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

Model Number V60 PLUS

Device Problem Gas Output Problem (1266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: (b)(4).

Event Description

The customer reported, during use on a patient, the ventilator alarms for errors 1111-cbit o2 device failed and 1208-o2 unavailable with s/n (b)(4).The staff replaced the faulty unit with another v60 s/n / (b)(4), and the treatment resumed.No harm to the patient and no adverse effects were reported.The s/n (b)(4) was reported under philips reference# 2573913/ mfr reference# 2031642-2022-02793.Event time sn / (b)(4).1208,10:21.33pm,10-10-2022,o2unavailable, 1111,10:21.33pm,10-10-2022,cbito2 device failed.

Manufacturer Narrative

The unit was checked after the reported incident and no fault was found.During follow up with the customer, it was reported that a performance verification was performed, and the device was returned to service.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 15756967
• MDR Text Key: 303559517
• Report Number: 2031642-2022-02774
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 PLUS
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/25/2022
• Date Device Manufactured: 10/09/2020
• 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