MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of " the autopulse platform (sn: (b)(4)) displayed user advisory (ua)41 (patient temperature sensor failure) error message upon powering up" was confirmed based on the archive data review but not confirmed during the functional testing.No device malfunction was observed that could have caused or contributed to the reported ua41 error message.A review of the autopulse platform archive revealed that frequent daily checks were performed by the customer.As reported by the customer, the autopulse platform was stored in their ambulance.Factors such as ambient storage condition (e.G.A fire truck sitting in a hot and humid environment and/or being exposed to direct sunlight for long hours) as well as using the platform on a soft surface that may block air vents will increase the internal temperature of the autopulse platform and can cause the occurrence of a ua41 error message.There was no physical damage observed on the returned autopulse platform during the visual inspection.A review of the autopulse platform archive was performed and showed multiple ua41 (patient temperature sensor failure) error messages to have occurred on the customer's reported event date; thus, confirming the reported complaint.The autopulse platform passed initial functional testing without any fault or error, and therefore, the reported complaint could not be replicated.Furthermore, the autopulse was subjected to a run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged for 30 minutes, and the platform passed the test without any fault or error.Moreover, internal inspection of the autopulse platform was performed and found no fault or device malfunction.Nevertheless, the temperature sensor cabling was replaced as a preventive precautionary measure, as the sensor may have had some intermittent technical problems that could not be directly identified during the functional testing.After replacing the temperature sensor cabling, the autopulse was subjected to a run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged for 15 minutes, and the platform passed the test without any issues.Awaiting the customer's approval for repair.

Event Description

During shift check, the autopulse platform (sn: (b)(4)) displayed user advisory (ua)41 (patient temperature sensor failure) error message upon powering up.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10486274
• MDR Text Key: 209358005
• Report Number: 3010617000-2020-00847
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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