MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 (W B) ONSITE DEFIB, US ENGLISH,EXCHG; AED

Model Number M5066A

Device Problem Material Separation (1562)

Patient Problem Unspecified Heart Problem (4454)

Event Date 01/13/2023

Event Type  Death  

Event Description

2nd set: gel would not adhere to the backing, but there was no voice prompt; eventually the pads recognized the patient and were able to analyze after the customer pressed around the edges.I spoke with the (b)(6) yesterday, she called aed tech support to follow up on the hs1 pads recall and the status of the new pads.(b)(6) stated that they had a code on a patient an they were having trouble getting it to connect doing exactly what the recall says, and the patient end up dying.At the time of our call she did not say when this happened.She was expressing the concern of needing to have pads asap.I shared with her philips sales manager contact information for her to see if there is a possibility of finding pads with another distributor.I called the customer back a few minutes later and wanted to go over the mentioning of a patient dying.I asked her when did this happen, was this something that happen a long time ago, or most recently.She stated that this happened (b)(6) 2023.She stated that they had an issue with getting the first set of pads to "connect" and produce an analysis of the patients heart rhythm.(b)(6) stated that the aed kept stating to repeat the step over and over but the pads would not "connect" properly.I asked her if she could recall the message from the aed and she was not sure.(b)(6) then stated that they decided to place a second set of pads into the device, and they were able to get the pads to "connect".I asked if she is saying, due to the pads not connecting properly (sticking to the patient) is this the reason that the patient died.She stated that she is not saying that the pads are the reason the patient died.She stated that the pads not connecting properly caused a delay in resuscitating the patient.(b)(6) stated that with the second set of pads they were able to revive the patient and the ems then transferred the patient onto their equipment.(b)(6) further stated that the patient had passed away later that day.She again stated that it was not the pads that were the reason for the patient¿s death.I asked her if this something that she reported because i can imagine and event like this would need to be documented.She stated that she documented on their end.I asked if this have been reported to philips, she replied yes.I continued to collect information on the company and contact information in addition to the aed serial number and pads lot number.I asked for the pads lot numbers and expiration dates and she informed that the aed pads are no longer with them.(b)(6) informed that the ems took their trash from the event.I asked if she knew the lot number and she stated that all they were able to get from the aed pads as a lot number was y03.She stated that they have no other information.Aed serial number (b)(6).Pads information was not obtained due to customer throwing them away.

Manufacturer Narrative

Based on the available details, the evaluation determined that an investigation was required however it's not possible since the pads were discarded.The customer was provided with a replacement pads.Based on the information available, the potential cause of the reported problem was a potential component failure.The reported problem and the root cause could not be confirmed because the pads are not available for investigation since the customer discarded them right after the event.However, the device was returned to full functionality when the replacement pads were received by the customer.Based on the information available, no further action is necessary at this time.Insufficient information is available to support final failure analysis.The pads are not available for investigation due to being discarded by the customer.The customer was provided a replacement pad to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Available details indicate that the gel would not adhere to the backing of a second set of pads used on a patient.There were no voice prompts noted and after the customer pressed around the edges, the patient connection was recognized, and the device proceeded with analysis.The evaluation based on the available details determined that a clinical investigation was required.The assigned product support engineer received the device¿s patient event file, which was sent to the ecr senior medical solutions specialist for review.The clinical investigation determined that the shock button was pressed at one minute and thirteen seconds elapsed time, but no shock was delivered because the pads were not connected to the patient.Subsequent activity in the event file recorded blue (information) button and on/off button presses, although the device was not powered off because the button press was not long enough.The pads cartridge then appeared to have been reinstalled or replaced by an additional cartridge.The first ecg analysis began at two minutes and ten seconds elapsed time.The analysis showed the ecg rhythm to be ventricular fibrillation.The aed correctly identified the rhythm as shockable and a shock was delivered, converting the ecg to an idioventricular rhythm.A two-minute pause for cpr followed.The second ecg analysis showed the ecg rhythm to be ventricular fibrillation.The aed correctly identified the rhythm as shockable and a second shock was delivered, converting the ecg to an idioventricular rhythm.This was followed by a ¿pads off¿ message and the aed was powered off after nine minutes and six seconds.An analysis of the device history did not find any evidence of device failure, but there is insufficient information available for final failure analysis because the pads were disposed of following the event and were not available for investigation.The customer was provided replacement pads to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: HS1 (W B) ONSITE DEFIB, US ENGLISH,EXCHG
• Type of Device: AED
• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16867870
• MDR Text Key: 314546353
• Report Number: 3030677-2023-01869
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838075849
• UDI-Public: 00884838075849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: M5066A
• Device Catalogue Number: 453564592771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 05/22/2023; 01/30/2024
• Supplement Dates FDA Received: 05/22/2023; 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1