MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC HEMOPOD; SIMULATORS, INVASIVE BLOOD PRESSURE

Catalog Number	MS20725
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported inaccurate readings.The anesthesia assistant reported that the mpod quad hemo gave "inaccurate" arterial values and required re-zeroing to get accurate values.The users re-zeroed the qua hemo three times, and then replaced it with another device.Once the users switched to the other quad hemo, the hemo gave the expected pressures.The biomed at the customer site had tested the device on an edwards ibp simulator with no malfunction found and returned it to service.The malfunction occurred again on june 30th.The customer biomed tested again and found that the pressures would not change from 0mmhg intermittently, when it was then reported to draeger.No adverse patient impact or patient death was reported.
Additional Manufacturer Narrative
The device was returned to draeger for evaluation.During testing, engineering was able to confirm that the main printed circuit board assembly (pcba) from the cited pod was the cause of the inaccurate readings.The pcba was replaced and draeger performed testing of the device to confirm full functionality of the pod.Service provided the quad hemo mpod to logistics for customer return and clinical use.
Event or Problem Description
The customer reported inaccurate readings.The anesthesia assistant reported that the mpod quad hemo gave "inaccurate" arterial values and required re-zeroing to get accurate values.The users re-zeroed the qua hemo three times, and then replaced it with another device.Once the users switched to the other quad hemo, the hemo gave the expected pressures.The biomed at the customer site had tested the device on an edwards ibp simulator with no malfunction found and returned it to service.The malfunction occurred again on june 30th.The customer biomed tested again, and found that the pressures would not change from 0mmhg intermittently, when it was then reported to draeger.No adverse patient impact or patient death was reported.

• Brand Name: HEMOPOD
• Common Device Name: SIMULATORS, INVASIVE BLOOD PRESSURE
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784828529
• MDR Report Key: 20190075
• Report Number: 1220063-2024-00104
• Device Sequence Number: 7180139
• Product Code: MHX
• UDI-Device Identifier: 04049098003667
• UDI-Public: (01)04049098003667(93)MS20725-08
• Combination Product (Y/N): N
• PMA/510(K) Number: K070566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: MS20725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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