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

Model Number V60

Device Problem Power Problem (3010)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Date of report: 03aug2021.

Event Description

The customer reported the unit won't work without being plugged in.The patient was swapped out to another unit by ambu bagging with supplemental oxygen.There was no harm to patient as respiratory therapist (rt) was at bedside and was able to get another unit.The remote service engineer (se) confirmed that the unit does not run on battery power, only (ac) alternating current.The battery light-emitting diode (led) is flashing.The se found battery voltage low at 12.5 vdc.The fse advised charging the battery overnight.The customer allowed the unit to remain in place for 16hrs+ for a proper charge of the batteries.The investigation is ongoing.

Manufacturer Narrative

Upon follow up, the customer reported that proper charging for more than 16 hours resolved the issue.Repairs were not needed.Unit has passed performance specifications since then.The device is back in service.Based on the information provided by the customer, there was no product malfunction.The root cause of the issue was traced to inadequate battery charging.This complaint has been downgraded from a serious injury to product problem as the provision of manual ventilation with supplemental oxygenation is a standard clinical approach to safeguard the patient's airway prior to being transitioned to a secondary ventilator.No patient harm or injury was incurred.

• 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: 12268824
• MDR Text Key: 264795148
• Report Number: 2031642-2021-04478
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,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 Operator: Health Professional
• 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: 07/22/2021
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/15/2022
• Date Device Manufactured: 09/24/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention