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

Catalog Number	130003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the battery case was broken.Patient involvement is unknown.
Event or Problem 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.
Additional Manufacturer Narrative
Other text: h6.Health effects; updated.G1,2 email is: regulatory.Responses@icumed.Com.
Additional Manufacturer Narrative
One device was returned for analysis.Visual inspection confirmed the customer's complaint.Battery compartment is damaged.However, this is not due to case damage but because the screw that holds it in place was missing.The root cause for this event is the impact on device.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record review was not performed.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.D.4.Full udi number: (b)(4).

• Brand Name: PNEUPAC PARAPAC VENTIPAC WITH ALARM
• Common Device Name: 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
• Report Number: 3012307300-2023-08190
• Device Sequence Number: 12440905
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: 10610586038259
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 06/18/2024
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 12/21/2023; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown