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

Model Number V60

Device Problems Failure to Charge (1085); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6)2021.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

The customer is requesting priority implementation for the unit as it appears the unit is not charging the battery.Per biomed the issue was discovered during patient transport.The customer contacted product support and requested for service repair.Product support emailed the customer letter for fsn86600050 parts availability update.Product support advised the customer that an fse will contact them to schedule remediation as they work through the list and the fco cases.The customer reported that the unit was in use on a patient, but there was no patient harm reported.Per the biomed, the issue was discovered during patient transport.The unit was swapped.No delay in therapy and no medical intervention reported.The unit will be repaired under fco86600050 to address the reported issue.Product support created an action assignment for philips long term planners.The unit is schedule to undergo field change order.

Manufacturer Narrative

The biomedical engineer (bme) reported that the yellow amber light charging the v60 battery is not lit when connected to ac power.The bme confirmed there was no 24-volt power supply on the brown and orange molex connector of the power management board.The product support advised the customer to order power supply and provided its part id.The authorized service engineer (ase) replaced the power management board but the battery not charging issue was not corrected.Multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.It is unknown if any parts or repair has been conducted.The complaint will be processed for closure.If additional information is later obtained, the complaint will be reopened.

• 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 (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11289090
• MDR Text Key: 244200879
• Report Number: 2031642-2021-00449
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1622-2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER