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

Model Number	V200DNUS
Medical Device Problem Codes	Material Disintegration (1177); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported the device was dropped and had a broken battery door.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
B5, h6: addtional information.One ventilator was returned for evaluation.Visual inspection of the device found the battery holder damaged, and both the battery and battery door missing.Upon visual inspection of the device, the reported customer complaint was confirmed.Battery holder assembly noted to be damaged due to impact.The problem source has been determined to be user interface.
Event or Problem Description
Information was received that incident occured during inspection; no patient harm.

• Brand Name: PNEUPAC VENTILATORS VENTIPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• MDR Report Key: 9771679
• Report Number: 3012307300-2020-01595
• Device Sequence Number: 11316748
• Product Code: BTL
• UDI-Device Identifier: 35019315074183
• UDI-Public: 35019315074183
• Combination Product (Y/N): N
• 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): 06/08/2020

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: V200DNUS
• Device Catalogue Number: 130003V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 06/08/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2005
• 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: Unknown
• Patient Sequence Number: 1