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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6).Date of report: 20aug2019.

Event Description

Central processing unit (cpu) failure.There was no patient involvement.

Manufacturer Narrative

Date rec'd by mfr: 21nov2019.The part was returned to the manufacturer for failure investigation (fi).This failure was caused by a defective flash ic u1 (lot code: p33bf70).Installing a good failure investigation (fi) test flash ic u1 corrected the problem with this central processing unit (cpu) printed circuit board assembly (pcba).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

Central processing unit (cpu) failure.There was no patient involvement.

Manufacturer Narrative

G4: 04sep2019; b4: 05sep2019.The manufacturer's service technician confirmed the cpu issue.The technician replaced the cpu pcba to address this issue.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.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.

• 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
• MDR Report Key: 8911931
• MDR Text Key: 170687658
• Report Number: 2031642-2019-06661
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: (01)00884838009851
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2019

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 08/02/2019
• Supplement Dates FDA Received: 09/05/2019; 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1