MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number P310NUS

Device Problems Circuit Failure (1089); Optical Problem (3001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event is unknown, no information has been provided to date.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.

Event Description

It was reported that the device needs repair and preventative maintenance (pm).The issue reported: the spontaneous breath does not function or light up.Patient involvement is unknown.

Event Description

Additional information received via email.There was no event date provided and the problem was found during routine inspection.

Manufacturer Narrative

Updated.Device evaluation: one device was returned for investigation.No major physical damage to report.Functional testing found the spontaneous breathing led illuminated as intended.The complaint was not confirmed.The most likely root cause of the reported issue was use error or equipment.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.No action taken for the reported issues.Performed preventative maintenance.Device passed functional testing., corrected data: email is: (b)(6).

• Brand Name: PNEUPAC PARAPAC PLUS
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17299320
• MDR Text Key: 319193633
• Report Number: 3012307300-2023-07091
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 35019315107263
• UDI-Public: 35019315107263
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P310NUS
• Device Catalogue Number: P310NUS
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1