MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

It was reported that there were multiple lines of ecg bias in association with cable failures.There was reportedly no patient involvement.

Event Description

It was reported that there were multiple lines of ecg bias in association with cable failures.There was reportedly no patient involvement.The manufacturer's authorized field service engineer (fse) evaluated the device and confirmed the reported problem.Upon conclusion of the evaluation, it was determined that this was a malfunction of the processor pca, which was replaced and the device was returned to full functionality.The device remains at the customer site and no further evaluation is warranted at this time.

Manufacturer Narrative

The processor printed circuit assembly (pca), part number: 453563478461) with serial number: (b)(6), was returned to philips for failure analysis.The complaint was escalated for technical investigation and the results indicate the processor pca.Was fully evaluated and tested.The pca was visually inspected for signs of wear, damage, corrosion, or missing components, and no anomalies were found.The testing of the pca in a test fixture found no problems running the operational check.The test fixture device had no charging for discharge issues.An ecg functional test was performed by connecting the ecg cable to the defibrillator analyzer set for ecg simulation of normal sinus rhythm (nsr), 1.00mv amplitude, and 60bpm.Mrx display showed a clear waveform for all leads and pads as selected.There were no problems found with the processor pca based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.The bench engineer provided their analysis.The reported allegation about the " multiple lines of ecg bias, cable failure / replaced processor pca¿ was not verified nor duplicated during lab tests.The processor pca passed all tests during the op check and performed as expected.Therefore, there is no fault found (nff) with this processor pca.The investigation concludes that no further action is required at this time.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: lois price ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 11768146
• MDR Text Key: 248752363
• Report Number: 3030677-2021-11290
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/07/2021
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1