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

Model Number V60

Device Problems Loose or Intermittent Connection (1371); Device Fell (4014)

Patient Problem Bruise/Contusion (1754)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 06june2020.

Event Description

A customer reported to philips that the support arm bracket loosened and fell off a v60 ventilator and hit a patient in the face, causing a bruise.It is unknown if the device was in use at the time of the patient incurring the adverse event.

Manufacturer Narrative

G4: 10jun2020; b4: 11jun2020.The device was not in use at the time of the patient incurring the adverse event.There was no request for a field service engineer (fse) onsite visit and no service order was opened in regards to this allegation.This complaint was received through the customer feedback process.There was no request for technical support regarding this allegation and there is no record of a service order being opened.No parts were replaced.The hospital staff removed the circuit support arm bracket from the device.The device remains at the customer site and no further evaluation is required at this time.This respiratory therapist stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported, and was prescribed hora somni (hs) therapy via the respironics v60 ventilator; device mode, settings, and configuration not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on 27may2020, the patient was not receiving therapy from the ventilator, the patient¿s nurse moved the ventilator in order to reach the suction set-up, and the v60¿s circuit support arm bracket fell on the patient¿s face and caused a bruise.No medical intervention was reported.The hospital staff removed the support arm from the device.No relevant laboratory data was reported.There is no information to support that a malfunction occurred or that the device failed to meet specifications.The circuit support arm bracket is not an essential part of the device, and the device can deliver therapy with or without the bracket.There is a certain association between the nurse moving the ventilator and the arm falling onto the patient's face, causing the non-serious adverse event.The cause of the event was due to operator error.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: 10126543
• MDR Text Key: 194299206
• Report Number: 2031642-2020-01995
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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 Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/06/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER.
• Patient Outcome(s): Other