MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event of the autopulse platform (sn (b)(4)) was confirmed.The autopulse platform passed initial functional testing without any fault or error.Load cell characterization test during final testing revealed load cell module 2 was over reported.The root cause was due to the defective load cell 2.Upon visual inspection, noticed that the encoder drive shaft does not rotate smoothly, exhibits binding and resistance, unrelated to the reported complaint.The clutch plate was deburred to remedy the issue.The autopulse platform is a reusable device and was manufactured in 2007 and is 12 years old, well beyond the expected service life of five years.Therefore, this type of damage found during visual inspection is characteristic of normal wear and tear for the life of the device.Review of archive data showed occurrence of multiple ua07 (discrepancy between load1 and load2 too large) and ua02 (compression tracking error occurred on the first compression) error message on the customer reported event date.The archive data review showed that during power-on-self-test, the load sensing system has detected a weight/load imbalance between the two load cells and the size of the patient/object was too small and light in weight during the take-up.Load cell characterization test revealed load cell module 2 was over reported.The cause for the error message was due to the defective load cell 2.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial number (b)(4).

Event Description

As reported, during patient use, the autopulse platform (sn (b)(4)) stopped before performing compression.Per user, the platform appeared to pause while sizing the patient and stopped before touching the patient's chest.Immediately, the crew proceeded with manual cpr.Per user, the patient care was not compromised.The user checked the platform back at the station with mannequin and the platform displayed ua07 (discrepancy between load 1 and load 2 too large) and ua02 (compression tracking error) error messages.No known impact or consequence to patient information was available.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8321704
• MDR Text Key: 136151867
• Report Number: 3010617000-2019-00082
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2007
• 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