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

Model Number V60

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

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

Event Date 06/15/2022

Event Type  malfunction  

Event Description

The philips field service engineer (fse) reported that the ventilator blower was loud, and revolutions per minute (rpm) were fluctuating.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.The device was evaluated by the customer and a philips remote service engineer (rse).The customer verified the blower was loud.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

The philips field service engineer (fse) reported a ventilator blower was loud and revolutions per minute (rpm) fluctuating during preventative maintenance (pm).Further information was requested and currently pending.

Manufacturer Narrative

The remote service engineer (rse) advised the customer that they may need to replace the blower assembly and provided the part identification number.Moreover, the customer reported that they informed the biomed's that they would have to order the part and have it serviced at a later time and the unit was pulled from service.It is unknown if any parts or repairs have been conducted.Multiple attempts were made to retrieve device repair or diagnostic information, however, yielded no response from the customer.

• 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: 14856450
• MDR Text Key: 301738905
• Report Number: 2031642-2022-01748
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• 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 Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 06/29/2022; 08/05/2022
• Supplement Dates FDA Received: 07/26/2022; 08/29/2022
• Date Device Manufactured: 02/20/2015
• 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