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

Catalog Number 130003

Device Problem Break (1069)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

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 battery case was broken.Patient involvement is unknown.

Event Description

Additional information received via email.The event occurred during testing.Event date was updated from unknown to 02-march-2023.The was no patient involvement.

Manufacturer Narrative

Other text: h6.Health effects; updated.G1,2 email is: regulatory.Responses@icumed.Com.

• Brand Name: PNEUPAC PARAPAC VENTIPAC WITH ALARM
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17565215
• MDR Text Key: 321448533
• Report Number: 3012307300-2023-08190
• Device Sequence Number: 1
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1