MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MODEL EMV+, COMM, MRI; VENTILATOR

Model Number	799-EMVP-05-01
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Power Up (1476); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during functional testing, the device would intermittently not power up and displayed "compressor fault - 1001" and "self check failure - 1172" messages.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
The customer's report was observed during evaluation of the device.The compressor was found to be compromised.It is likely that this ventilator was stuck to the mri machine gantry causing damages to the device.The customer declined repairs; therefore, the device was labeled not for clinical use and returned to the customer.According to the zoll ventilator's operator guide: to ensure safety, the ventilator must be secured to an mri compatible cart and be placed behind the 130 gauss field line, at least 2 meters from a 3t mri magnet.A dedicated person must monitor the device and the patient, and alarms should be visually checked.The rolling stand must be locked and tethered.These steps help prevent injury and equipment malfunctions within the mri environment.Analysis of reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The customer was contacted and discussed the specifications related to mri distance.The customer is aware.

• Brand Name: MODEL EMV+, COMM, MRI
• 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: 21179789
• Report Number: 1220908-2025-00022
• Device Sequence Number: 12912317
• Product Code: CBK
• UDI-Device Identifier: 00847946023430
• UDI-Public: (01)00847946023430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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-05-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/23/2025; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2130-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown