MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; V60 VENTILATOR WITH PPV AND AUTO-TRAK+SOFTWARE OPTIONS

Model Number V60

Device Problem No Device Output (1435)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported to philips that the device was defective and did not provide any ventilation.The exact failure was not specified.Additional information has been requested.

Manufacturer Narrative

Additional investigation information was provided from the philips senior field service engineer who stated that the device was defective and did not provide any ventilation.The exact failure was not specified.The drpt was obtained.Upon further investigation, the product support engineer informed that the service technician who was dispatched to customer site to implement an fco found the device totally defective (no ventilation) situated out of icu ¿ in a room where customer put all defective equipment.It is unknown if the device was in clinical use at the time of the event.There was no report of patient or user harm/impact.Upon attempt to get repair information, the field service engineer informed that the reported device is in a state hospital and the hospital does not have budget for replacement of spare parts now.Further attempts to retrieve device repair or diagnostic information has yielded no response from key market team.Therefore, it is unknown if any part was replaced or if repair has been conducted.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened and a supplemental report will be submitted.

• Brand Name: RESPIRONICS
• Type of Device: V60 VENTILATOR WITH PPV AND AUTO-TRAK+SOFTWARE OPTIONS
• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 11682939
• MDR Text Key: 246460459
• Report Number: 2031642-2021-03348
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2021
• Supplement Dates Manufacturer Received: 07/17/2022
• Supplement Dates FDA Received: 07/21/2022
• Date Device Manufactured: 07/10/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1