MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Alarm Not Visible (1022)

Patient Problem Cardiac Arrest (1762)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The biomed reported that a patient coded at 23:09 on (b)(6) 2021.They want to review the alarm logs for potential failure to alarm for spo2.

Event Description

The biomed reported that a patient coded at 23:09 on (b)(6) 2021.They want to review the alarm logs for potential failure to alarm for spo2.

Manufacturer Narrative

According to the telemetry technician, the piic was tested on october 19, 2021 and appeared to be working as specified.The telemetry technician observed the pleth on other patients and there was no spo2 value but ¿?¿ instead.The pulse ox is set to <90%.The mx40 device was not returned for evaluation.Pictures of the philips 989803199091 patient cable with spo2 adapter were provided by the fse and reviewed by the philips product support engineer (pse).The masimo spo2 sensors being used are the masimo set lncs series adtx (adult size), which are approved for use with the mx40 with spo2 option s02 (fast spo2).Regarding problems with the spo2 measurements, please note that application of the spo2 sensor may affect spo2 measurements.The instructions for use (ifu page 99) instructs the user, ¿failure to apply a sensor properly can reduce the accuracy of the spo2 measurement¿if a sensor is too loose, it can compromise the optical alignment or fall off.¿ it is very important to properly align the led and photo detector (directly opposing one another through the nail bed) to ensure optimal signal capture for analysis of data.Alarm logs review: our pse reviewed and provided an assessment of the log data provided by the fse.According to the pse, the pic classic did not have the clinical audit logs.The following information for bed label tel56 is from the pic junk.Dat file.There were two spo2 ***desat alarms generated and silenced during the reported incident timeframe.Note that the log only captures ***red alarms; therefore, it cannot be determined what other limit violation alarms or technical inops may have been provided.The following is from the mx40 pwm logs (as previously noted): with regard to mx40 pwm log information, the following is data around the incident timeframe.The only mx40 device ¿activity¿ around the incident timeframe was a battery change at 20:42 on (b)(6) 2021.Mx40 pwm log information follows: (b)(6) 2021 20:42:46.75 cbatteryprocess::setup: startup battery voltage is 4711 mv (b)(6) 2021 20:42:48.26 pwmmain(revision: b.06.59 date: (b)(6) 15:31:43 edt 2019): pwm reboot.(b)(6) 2021 20:43:28.93 processmicrophone: passed.Startup fail=0, pass=0, fail=0, vol=0, sharp=0 the corresponding excerpts from the pic junk.Dat file during the time of the event provided above are shown as follows: 23:10:58.593 (b)(6) 2021 : sdprocess tel56 alarm *** desat 66 < 80.23:10:59.078 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:05.921 (b)(6) 2021 : sdprocess silenced tel56 *** desat 66 < 80.23:11:06.093 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:38.500 (b)(6) 2021 : sdprocess tel56 alarm *** desat 71 < 80.23:11:38.750 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:40.234 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:41.203 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:42.265 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:43.312 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:45.312 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:48.593 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.23:11:54.593 (b)(6) 2021: sdprocess tel56 red alarm sound -arrhy.23:12:13.328 (b)(6) 2021 : sdprocess silenced tel56 *** desat 66 < 80.23:12:13.343 (b)(6) 2021 : sdprocess tel56 red alarm sound -arrhy.Based on philips¿ review of the logs and provided images, there is no evidence to support a malfunction of the philips device.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12771282
• MDR Text Key: 280466495
• Report Number: 1218950-2021-11081
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 97 KG