MAUDE Adverse Event Report: NULL PNEUPAC PARAPAC VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number P310NJ

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

It was reported that during the maintenance checkup, looseness in the air circuit connection part was observed.No patient injury was reported.

Manufacturer Narrative

Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection did found the device intact.The customer stated problem was duplicated.Because the load in the loosening direction is applied when the patient circuit is attached or detached.Tighten the patient circuit connector, functional tests and performance tests were conducted.The cause of the reported problem could not be determined.This is not a problem related to previous smith repairs.

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The cause of the reported problem could not be determined.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: PNEUPAC PARAPAC VENTILATOR
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 13952732
• MDR Text Key: 294054264
• Report Number: 3012307300-2022-05536
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P310NJ
• Device Catalogue Number: P310NJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1