MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PNEPAC PARAPAC PLUS VENTILATION KIT W/ INTERNAL PEEP & CPAP; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number P310NUS

Device Problems False Alarm (1013); Pressure Problem (3012)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that there was an issue with the low-pressure alarm going off after a few minutes.There was patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

Date of event: unknown.No information has been provided to date.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: PNEPAC PARAPAC PLUS VENTILATION KIT W/ INTERNAL PEEP & CPAP
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; bijsterhuizen 22 ¿ 08; wijchen 6604 LD; NL 6604 LD
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18841458
• MDR Text Key: 337194653
• Report Number: 3012542015-2024-00009
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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