MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA - 1001

Device Problem Suction Problem (2170)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

Lot number is not currently available for this event.Request sent to site for lot number, no response to this request to date.A good faith effort to obtain lot number has been attempted.The health care provider in this event reports a human error in setting the device up to suction that caused the jada device to malfunction.As the type of malfunction was not identified, we cannot rule out that its recurrence is likely to cause or contribute to a death or serious injury.Therefore, this event will be reported as a malfunction mdr.

Event Description

On december 28, 2021, alydia health received a completed jada experience survey (jes) form that reported jada stopped the postpartum hemorrhage (pph) in "greater than 10 minutes" and noted, "jada did not work well initially due to human error by ancillary staff in setting up suction correctly.After correction made, device no longer really." in the area on the survey designated for feedback when jada did not stop bleeding'.Note: the above noted quote is incomplete in the survey form, so copied as such here.The site has been requested to complete this sentence in the record but has not yet replied as of the date of this summary.The event date for this survey is (b)(6) 2021.This patient is described in the survey as having pph starting 1-6 hours after an emergency cesarean section (c-section) delivery.She has a medical history of pre-eclampsia with this pregnancy.Prior to jada use, she received 1 unit of hemabate, 1 unit of cytotec, and 2 units of txa.The patient's blood loss prior to jada use was reported as 3500 ml, which is severe pph.The amount of blood noted as evacuated with jada was less than 100 ml.A request was made for follow up information and clarification of the jes form.On january 9, 2022, alydia health employee received an email response to clarification requested from the health care provider that stated there was a "malfunction due to human error with suction setup." there was no additional information or clarification provided.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way; menlo park CA 94025
• Manufacturer Contact: heather wisler ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 13350022
• MDR Text Key: 286667750
• Report Number: 3017425145-2021-00048
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JADA - 1001
• Device Catalogue Number: JADA - 1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female