MAUDE Adverse Event Report: ST PAUL PNEUPAC PARAPACVENTIPAC TRANSPORT MODEL; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	130003
Medical Device Problem Codes	Break (1069); Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, 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 or Problem Description
It was reported that the battery cover was damaged.Patient involvement is unknown.
Additional Manufacturer Narrative
Other text: d4 udi: (b)(4).One device was received for investigation.The device was visually inspected and functionally tested.The battery compartment was damaged and the cap is missing.The complaint is confirmed.The root cause is due to physical impact to the device.Replaced battery compartment.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.G2 email is: regulatory.Responses@icumed.Com.

• Brand Name: PNEUPAC PARAPACVENTIPAC TRANSPORT MODEL
• 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: 17464225
• Report Number: 3012307300-2023-07819
• Device Sequence Number: 11437578
• 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
• Report Date (Section B): 06/26/2024

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?: Device Returned to Manufacturer
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2017
• 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