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

Model Number 310

Device Problems Component Missing (2306); No Flow (2991)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical pneupac parapac plus doesn't breathe.It was reported that the pressure maxes out at relief pressure after 50 percent o2 and switched to ventilator airway.The oxygen ball was also noted to stay white.There were no reported adverse effects.

Manufacturer Narrative

Other text: one pneupac ventilators parapac plus was returned for analysis.Upon visual inspection the cpap knob cap was noted to be missing.Functional testing performed; no discrepancies found.The unit was observed to be delivering accurately to the test lung, passed the lock-off leak test and the cycle indicator flashed appropriately after running for two hours.Based on the evidence, no fault was found as the allegation was not confirmed.

• Brand Name: PNEUPAC
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 10109136
• MDR Text Key: 193322391
• Report Number: 3012307300-2020-05408
• 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: 07/28/2020

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: No Information
• Device Model Number: 310
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1