MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Unexpected Shutdown (4019)

Patient Problem Respiratory Arrest (4461)

Event Date 07/29/2022

Event Type  Injury  

Event Description

The institutional biomedical engineer (bme) reported that the v60 unit was sent to him from respiratory with a vent inop.There was a black screen with error 100a on it consistent with vent-inop: data acquisition pcba adc reference failed.A 66-year-old female (weight: 46.2 kg) was placed on the v60 ventilator using respironics disposable breathing circuit, inline fep (with or without filter) or dep disposable circuit, ref.312118, lot 211228 with ventilator set to 1 second at 80% fio2 for an unspecified indication.On (b)(6) 2022, while the device was in clinical use, the unit went inoperable, had a black screen with error code 100a (da pcba adc reference failed).There were no audible alarms at the time of the event.The current total power on hours of the ventilator was 13702.Patient harm was noted, with condition noted as respiratory distress, and near respiratory arrest, was cyanotic with oxygen saturation of <60%.The malfunctioning device was removed, and the patient was immediately intubated.The institutional biomedical engineer (bme) was unable to duplicate the vent inop but noticed several codes in the event log (drpt) history.The event log generated 100a,05:23.22am,07-29 2022,cbitdataadcreferencetestfailed.Subsequent diagnostic codes recorded included 1008, 2002, 1106, 1107, 1007, 1110, 110e, 110f, 1113, 1102, 1104, 1105, 1118, 1127, 111b, and 1115.The bme noticed while in the significant log, the time and date had zeros on some of the lines.The unit has software 2.10, and these options, ppv, avaps, cflex, ramp, and auto +.The bme sent a copy of the drpt to a philips remote service engineer (rse) who recommended cpu pcba replacement.The customer is taking responsibility to correct/repair the device.Philips fse recommended replacing the cpu pcba.The customer has the part on order and is waiting for its arrival as it is on backorder.The customer has been notified to contact philips if this does not address their device issue.

Manufacturer Narrative

The repair for this unit cannot be conducted at this time due to the cpu pcba being on back order without an estimated time of availability.The material has already been requested and an order for the part was placed.The material ordered, cpu pcba, aligns with the recommended repair of the reported malfunction per the service manual.When the part becomes available, the repairs will be completed.If new information is received and suggest that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.No part has been received for failure investigation at this time, so the root cause of the failure cannot be confirmed.If the defective part is returned or new information is received, a supplemental report will be submitted.

Manufacturer Narrative

Customer completed the cpu (central processing unit) pcba (printed circuit board assembly) replacement as the rse (remote service engineer) previously identified as the required repair.Following replacement, the customer required remote troubleshooting for driver and software corrections.Troubleshooting was successful, the unit was confirmed to be functional and returned to use.The failed component was scrapped by the customer after they performed their own repairs, despite manufacturer request for component return.Due to the disposition of the failed part no failure investigation could be conducted, therefore the root cause of the failure at the component level cannot be determined.Trends for this type of issue will continue to be monitored to determine if additional actions are required.The investigation concludes that no further action is required at this time.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 15258893
• MDR Text Key: 298221283
• Report Number: 2031642-2022-02182
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 11/30/2022; 11/30/2022
• Supplement Dates FDA Received: 12/23/2022; 01/26/2023
• Date Device Manufactured: 12/04/2015
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 46 KG