MAUDE Adverse Event Report: NULL PNEUPAC VENTILATOR; CIRCULATOR, BREATHING-CIRCUIT

Device Problem Alarm Not Visible (1022)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Customer reported problem: cycle indicator does not flash.Is the customer's reported problem related to a previous smiths repair: no previous service history.Tamper seal removed / broken: no.Physical condition of the device: good.Evaluation tests or methods used to replicate the reported problems: tested to service manual level 1 10004212-003.Reported problem duplicated / replicated: yes.What caused the reported (primary) problem?: broken wire connecting sensor to chassis.Who caused the reported problem?: unknown.Actions / repairs done to correct the reported (primary) problem: chassis will be replaced during completion at (b)(4).Repair summary: chassis will be replaced during completion at (b)(4).Device passed functional tests: the device passed all other tests - final test will be completed after the chassis change at (b)(4)service center.

Event Description

It was reported that the cycle indicator led does not flash.No patient injury was reported.

• Brand Name: PNEUPAC VENTILATOR
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 13456012
• MDR Text Key: 287609565
• Report Number: 3012307300-2022-02586
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1