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

Model Number V60

Device Problem Excessive Heating (4030)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

The customer reported the unit gave check vent alarm for blower temp high.The customer checked the air inlet filter were not dirty or blocked.The remote service engineer (rse) advised checking that the cooling fan was operational, replacing the blower and motor controller (mc) printed circuit board assembly (pcba).The unit was in clinical use and there was no patient harm.

Manufacturer Narrative

G4:31may2021.G5:510k: k102985.B4:30jun2021.The customer could not confirm or duplicate the reported failure.The customer ran the unit to try to duplicate the error, and it did not duplicate.The unit was tested, and it was returned to service.No parts were replaced.

Manufacturer Narrative

B4:(b)(6)2021.It was confirmed with the equipment technician that the device was in clinical use; no patient harm.The unit was swapped out, and the patient was bagged.

Manufacturer Narrative

Based upon the information received from the institution, no harm or injury had been noted during the event in question.Administration of manual ventilation was conducted preventatively during the device transition, thereby preventing any manifestation of clinical change of condition to the patient.Based upon this information, the complaint record shall be amended with appropriate competent authorities to reflect the allegation of product problem and not a patient serious injury.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 11637767
• MDR Text Key: 244602997
• Report Number: 2031642-2021-03302
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Distributor Facility Aware Date: 03/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 05/31/2021; 07/26/2021; 11/09/2021
• Supplement Dates FDA Received: 06/30/2021; 07/28/2021; 12/08/2021
• 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
• Patient Outcome(s): Required Intervention