MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART HOME; AED

Model Number M5068A

Device Problems Device Difficult to Setup or Prepare (1487); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

It has been reported that the device would not pass the initial set up.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: HEARTSTART HOME
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 11282846
• MDR Text Key: 231316269
• Report Number: 3030677-2021-00241
• Device Sequence Number: 1
• Product Code: NSA
• UDI-Device Identifier: 00884838075849
• UDI-Public: (01)00884838075849
• Combination Product (y/n): N
• PMA/PMN Number: 020715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M5068A
• Device Catalogue Number: 861282
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1