MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number V200

Device Problems Defective Alarm (1014); Loss of Power (1475); Self-Activation or Keying (1557)

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

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09sep2020.

Event Description

The customer reported the unit turns off and all lights are flashing.The technical service coordinator (tsc) could not confirm the reported failure.The (tsc) performed the extended self test (est) and short self test (sst), 8.5.13 or the performance verification testing (pvt) and back up battery tests.The unit passed all tests without issue.The (tsc) could not duplicate any power issues like the account described.The unit was in clinical use, however there was no reported harm.

Manufacturer Narrative

G4: 30aug2020.B4: 11sep2020.H11: h1: b1 updated: patient was immediately bagged , while a back up ventilator was obtained, and transferred to another ventilator.More information has been requested regarding the patient.Age: 57, gender: female, weight: 220 lbs and height: 5¿7".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.

Manufacturer Narrative

G4: 27aug2020.B4: 11sep2020.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: V200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10509053
• MDR Text Key: 207179261
• Report Number: 2031642-2020-03172
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Age: 57 YR
• Patient Weight: 100