MAUDE Adverse Event Report: PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	130003V
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical pneupac parapac ventilator was reported to not be turning on.There were no reported adverse effects.
Event or Problem Description
(b)(4): it doesn't turn on.
Additional Manufacturer Narrative
One ventilator was returned for evaluation.Visual inspection of the device found it to have a damaged housing around the battery compartment and battery cap is also damaged and corroded.Device was then powered on, confirming the reported customer complaint as a result of a damaged battery cap.The problem source has been determined to be use interface.
Additional Manufacturer Narrative
One ventilator was returned for evaluation.Visual inspection of the device found it to have a damaged housing around the battery compartment and battery cap is also damaged and corroded.Device was then powered on, confirming the reported customer complaint as a result of a damaged battery cap.The problem source has been determined to be use interface.
Event or Problem Description
Ro 1056257: it doesn't turn on.

• Brand Name: PNEUPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 9970019
• Report Number: 3012307300-2020-03178
• Device Sequence Number: 11736334
• Product Code: BTL
• UDI-Device Identifier: 35019315074183
• UDI-Public: 35019315074183
• 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): 06/29/2020

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: No Information
• Device Model Number: 130003V
• Device Catalogue Number: 130003V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 04/16/2020; 04/16/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 06/23/2020; 06/29/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2011
• 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
• Usage of Device: N
• Patient Sequence Number: 1