Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHYSIO-CONTROL, INC. - 3015876 PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 350P
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2022
Event Type  malfunction  
Event Description
The customer contacted heartsine to report that their device did not provide voice prompts.Absence of voice prompts may lead to an inability understanding how to use the device correctly.This could result in adverse consequences.There was no report of patient use associated to the reported event.
 
Manufacturer Narrative
Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
 
Event Description
The customer contacted heartsine to report that their device did not provide voice prompts.Absence of voice prompts may lead to an inability understanding how to use the device correctly.This could result in adverse consequences.There was no report of patient use associated to the reported event.
 
Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault.The reported fault was attributed to pogo pins.The device was scrapped by heartsine and the customer was provided with a replacement device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PACKAGE, 350P,PP03J,JA,350-STR-JA-10
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer (Section G)
HEARTSINE TECHNOLOGIES LTD
207 airport road west
belfast BT3 9 ED
EI   BT3 9ED
Manufacturer Contact
todd bandy
207 airport road west
belfast BT3 9-ED
EI   BT3 9ED
4258674577
MDR Report Key16035918
MDR Text Key308458071
Report Number3004123209-2022-00168
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number350P
Device Catalogue Number350-STR-JA-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-