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

Model Number V60 PLUS

Device Problem Failure to Run on Battery (1466)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up report at the completion of the investigation.Internal cross reference: complaint pr# (b)(4).

Event Description

The customer reported problem in the ventilator belonging to the intensive care unit, the battery has depleted.It only works when plugged in to the main electrical power.Not in use, no patient or user harm reported.

Manufacturer Narrative

B4:(b)(6)2021 the customer confirmed the reported failure.The customer replaced the battery to resolve the issue.The unit was tested and it was returned to service.No part is returned, the customer recycled the battery.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• MDR Report Key: 11418763
• MDR Text Key: 235017154
• Report Number: 2031642-2021-03002
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 PLUS
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/18/2021
• Date Device Manufactured: 08/22/2020
• 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