MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL EMV+ VENT, ARMY; VENTILATOR

Model Number	799-EMVP-04-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during biomed testing, the device displayed an "internal comm failure -1175" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections d1 updated, d4 model # updated, d4 catalog # removed, and d4 primary udi # updated.Evaluation results: zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.Review of the device activity logs did not show any evidence to support the customer's report that a "self-check failure 1175" message was displayed at any time.Therefore, our investigation for this was unsubstantiated.The smart pneumatic module will be replaced as a precaution.The device will be recertified and returned to the customer once the repair estimate has been approved.No trend is associated with reports of this type.

• Brand Name: MODEL EMV+ VENT, ARMY
• Common Device Name: VENTILATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 19273715
• Report Number: 1220908-2024-01625
• Device Sequence Number: 18016077
• Product Code: CBK
• UDI-Device Identifier: 00847946020620
• UDI-Public: (01)00847946020620(21)AY16F000906
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2024

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: Other
• Device Model Number: 799-EMVP-04-01
• Device Catalogue Number: 799-EMVP-04
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/12/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown