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

Model Number 310

Device Problem Failure to Cycle (1142)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that when the device was tested twice, there was no cycle at airmix 50 but became normal at airmix 100 and ran normal when switched back to airmix 50.Issues occurred during bench testing of new stock.

Manufacturer Narrative

A product sample was received and is awaiting evaluation and 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.

Manufacturer Narrative

Other, other text: d4: model number: updated h6: health impact and evaluation codes: updated h10: manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found the device in good condition.Functional testing found no fault.Device passed all functional testing.No problem found.The regulator and timing valve assembly (b)(4) will be replaced at mczh service center as a precautionary measure.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: PNEUPAC VENTILATORS 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; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 11 lung tak st.; minneapolis, MN 55442
• MDR Report Key: 15628286
• MDR Text Key: 306427143
• Report Number: 3012307300-2022-24906
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 35019315107478
• UDI-Public: 35019315107478
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310
• Device Catalogue Number: 530A1167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1