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

Model Number M5066A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Choking (2464)

Event Date 09/21/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

The user is questioning the functionality of the device during this patient use event.The patient was choking at the time of the incident.The patient did not survive.

• Brand Name: HEARTSTART ONSITE
• Type of Device: AED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021 8431
• Manufacturer (Section G): PHILIPS HEALTHCARE - BOTHELL; 22100 bothell-everett hwy; bldg a; bothell WA 98021
• Manufacturer Contact: dana tackett ; 22100 bothell everett hwy; bothell, WA 98021-8431 ; 8887445477
• MDR Report Key: 5981052
• MDR Text Key: 55760742
• Report Number: 3030677-2016-02258
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K040904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M5066A
• Device Lot Number: .
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death