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

Model Number V60

Device Problems Fitting Problem (2183); Protective Measures Problem (3015)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Device is not working with new nurse call system.There was no patient involvement.Caller states that the facility got a new nurse call system that works the opposite of the old one and now the v60 does not trigger the alarm.Philips remote service engineer advised the caller to order the opposite nurse call cable from what they normally use.Part identification were provided for normally open and normally closed nurse call cables.

Manufacturer Narrative

Additional information received from customer via gfe.Biomed troubleshot with other v60 cables and determined the issue was not due to an incorrect cable, but rather caused by a faulty board.The part has been ordered but currently backordered.The device remains out of service.

Manufacturer Narrative

The repair for this unit cannot be conducted at this time due to the part(s) being on back order due to a global product hold.The material has already been requested and an order for the part(s) was placed to conduct the repair of this unit.The material ordered aligns with the recommended repair of the reported malfunction per the service manual.When the parts become available the repairs will be conducted.If new information is received and suggest that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

• 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: 15708080
• MDR Text Key: 306804918
• Report Number: 2031642-2022-02683
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,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 Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/10/2022; 12/06/2022
• Supplement Dates FDA Received: 11/28/2022; 12/07/2022
• Date Device Manufactured: 01/24/2011
• 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