MAUDE Adverse Event Report: ST PAUL PNEUPAC VENTILATORS PARAPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number 120003

Device Problem Circuit Failure (1089)

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

Event Type  malfunction  

Manufacturer Narrative

Operator of device is unknown.No information has been provided to date.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.

Event Description

It was reported that there was a faulty main board.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to a previous repair.Visual inspection found that the device with normal wear and tear on the housing.There was no evidence of the reported error in the event history log (ehl).The reported problem was not verified/duplicated during the investigation (unconfirmed ? no fault found).The device functioned as intended- the issue may be intermittent per the investigation.However, another problem was found with the pneumatic alarm failing.Yet, no corrective action was taken.The device was scrapped per customer request.The root cause of the reported issue was unknown.The previous service history was reviewed and deemed unrelated to the current customer reported problem.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PNEUPAC VENTILATORS PARAPAC
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15456315
• MDR Text Key: 306187677
• Report Number: 3012307300-2022-19795
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586045486
• UDI-Public: 10610586045486
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 120003
• Device Catalogue Number: 120003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1