MAUDE Adverse Event Report: ST PAUL PNEUPAC BABYPAC VENTILATOR WITH ALARMS; VENTILATOR, CONTINUOUS, FACILITY USE

Catalog Number	150003
Medical Device Problem Code	Defective Alarm (1014)
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 reporter would like to send the device in for preventive maintenance and for repair for the alarm not going off when disconnected.Patient involvement is unknown.
Additional Manufacturer Narrative
Email is: (b)(6), health effects codes updated.One device was returned for investigation.Visual inspection confirmed that the device was received in with a slight bow of the front panel on the left hand side of the manometer; gauge bezel is cracked.There are cracks on the top right corner of the housing, underneath the battery compartment, on the back of the housing, and on the gas/air supply indicators.External fittings are all corroded.Complaint is confirmed due to impact damages and device does not operate.No action taken, device has been deemed beyond economical repair due to extensive damage and obsolete parts needed to correct the reported problem.Device will be sent back to the customer unrepaired or scrapped on site.A device history (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: PNEUPAC BABYPAC VENTILATOR WITH ALARMS
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17433077
• Report Number: 3012307300-2023-07632
• Device Sequence Number: 20528051
• Product Code: CBK
• UDI-Device Identifier: 10610586045578
• UDI-Public: 10610586045578
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K970158
• 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): 03/11/2024

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: 150003
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/13/2023
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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