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

Model Number V60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Tightness/Pressure (2463); Abdominal Distention (2601)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

The determination could not be made that the device failed to meet specifications.The device was being used for treatment when the reported event occurred, and there is a relationship of the device to the adverse event.Gastric distention is a known patient issue with positive pressure ventilation.

Event Description

A physician reported that a patient had gastric distention.The patient was admitted for acute exacerbation of chronic obstructive pulmonary disease, heart disease, type 2 respiratory failure, respiratory acidosis, metabolic alkalosis and hypertension.The patient was on the ventilator for approximately one week, and on (b)(6) 2017, the patient had flatulence, could not lie supine and had chest tightness.The ventilator was removed and the patient was treated with tongli shenling graunules 10g for spleen and stomach three times a day) and domperiodone maleate tabs 12.7mg.After one week of treatment the patient has no further symptoms and the naso-gastric tube was not required any longer.

Manufacturer Narrative

The authorized service provider, (b)(4), confirmed there were no failures with the ventilator.It was confirmed that gastric dilation was a described side effect in the user manual.The clinical staff at the hospital were given further training on this.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6910209
• MDR Text Key: 87992365
• Report Number: 2031642-2017-03151
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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
• Patient Age: 67 YR
• Patient Weight: 64