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

Model Number P310NUS

Device Problems False Alarm (1013); Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported the device was giving "peak pressure" alarm after power on and device would not cycle.No adverse effects reported.

Manufacturer Narrative

Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PNEUPAC
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 11099485
• MDR Text Key: 224520955
• Report Number: 3012307300-2020-12903
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 35019315107263
• UDI-Public: 35019315107263
• Combination Product (y/n): N
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P310NUS
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1