MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PROPAQ; CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER AND RATE ALARM)

Device Problems Break (1069); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Respiratory Distress Syndrome of Newborns (2046); Tachycardia (2095); Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Date 06/03/2022

Event Type  malfunction  

Event Description

Propaq had a blood pressure cord (the plastic adapter for our cuffs) snapped in half while we were trying to leave the referral picu with a critically ill child.We did nothing other than use the equipment as intended and it snapped in half.This caused our monitor to be non-functional in terms of being able to take a blood pressure.We were unable to leave until another monitor was brought to us (2.5 hr delay) due to us being unable to obtain manual bp's in the rotor wing (noise constraint).The propaq was noted to have a broken connection on the blood pressure hose.While at the referral the team was able to obtain a blood pressure hose from a similar propaq, so they could return with this critical patient.The team also faced major time constraints with the pilots and their duty day.After placing new hose with referrals bp hose, the patient blood pressures were reading normal in comparison to the referral monitoring system.The crew decided to move forward with the transport.Shortly after departing the patients room the crew noticed that the blood pressures were soft and would require interventions.With the patient history and current acuity, they decided to return to the picu.Once the hooked the patient back up to the referral picu monitor there were significant differences between both cuffs.Regardless, the crew was required to increase vasoactive support.When the team initially departed to head towards our helicopter there was approximately 10 minutes remaining on their allotted ground time on the ground.The day pilots could change with the night pilots.When the helicopter returned it brought a new propaq.The new propaq seemed accurate.The referral blood pressure hose was removed, and the propaq hose was replaced.The propaq monitor was left in-service.Upon review, it was decided to remove the entire propaq from service so it could be tested to ensure that there aren¿t other bp related issues.The patient was monitored adequately during this time.Patient history- patient was inpatient female with complex past medical history transferred from outside facility due to concern for septic shock and multiorgan system dysfunction (acute on chronic respiratory failure, altered mental status, acute kidney injury, hypothermia, multiple electrolyte derangements).Patient presented to outside ed for 2-day history of abdominal distention and increasing oxygen requirements.Patient is avaps dependent at night and mother noted increasing fio2 needs over the last 2 days, mother reported saturations were drifting into the mid-70s to 80s and noted only marginal improvement with increasing fio2.Mother also noted patient's abdomen seem to be swelling, for this reason she was venting her g-tube and noted significant volume of light brown to yellow color output, no blood was noted.In the day prior to presentation mother also noticed altered mental status stated patient seemed less responsive and interactive than her baseline.Given these concerns, patient presented to other outside hospital emergency department.Patient was ultimately admitted due to temperature of 96.9 degrees, mild tachycardia, hypotension ranging from 50s/20s to 80s/50s with a pulse, oxygen saturation ranging from 65 to 81% with manual ventilation, patient was described as unresponsive and in extreme respiratory distress and no signs of improvement.Patient was originally admitted to the picu at outside hospital.However, due to her medical complexity and the fact that child is followed at our facility, she was transferred to our picu for higher level of care.

• Brand Name: PROPAQ
• Type of Device: CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER AND RATE ALARM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 15073730
• MDR Text Key: 296304923
• Report Number: 15073730
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2022

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
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Event Location: Other
• Date Report to Manufacturer: 07/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Female
• Patient Weight: 43 KG