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

Model Number M3536A

Device Problems Device Markings/Labelling Problem (2911); Naturally Worn (2988)

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

Event Date 01/24/2022

Event Type  malfunction  

Event Description

While performing onsite service of the device, it was identified by an authorized field service engineer that the labeling for the unit was damaged.The customer requested that an authorized field service engineer (fse) be dispatched to the customer site.Upon evaluation of the device, it was discovered that the labeling for the unit was damaged and required replacement.Based on the conclusion of the evaluation, it was determined that this was a malfunction of the therapy label.The therapy label was replaced to resolve the noted damage.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.

• 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: allison prater ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 14546296
• MDR Text Key: 292973289
• Report Number: 3030677-2022-02667
• 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
• Type of Report: Initial

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: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1