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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 12/29/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the product is returned and the investigation has ben completed.

Event Description

As reported, during deployment for patient use, the autopulse platform (sn# (b)(4)) displayed user advisory - ua07 (discrepancy between load 1 and load 2 too large) error message.The user was unable to clear the error message.No known impact or consequence to patient information was available.

Manufacturer Narrative

The reported event of "the autopulse platform (sn (b)(4) displayed "ua07 (discrepancy between load1 and load2 too large) error message" was confirmed through functional testing and archive data review.The root cause was due to the defective load cell module 1.Upon visual inspection, observed cracked top cover, unrelated to the reported event.The top cover was replaced to remedy the issue.The physical damage appear to have been caused by user damage.The autopulse platform failed initial functional testing due to ua07 (discrepancy between load1 and load2 too large) error message.The archive data review showed occurrence of ua07 (discrepancy between load1 and load2 too large) error message on the customer reported event date.The load sensing system has detected a weight/load imbalance between the two load cells, checked during power-on-self-test.Load cell characterization test indicated load cell module 1 was over reported.The load cell 1 was replaced to remedy the issue.Following service, the autopulse platform passed final functional test without any fault or error.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 previous history of complaints reported for autopulse sn (b)(4).

• 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
• MDR Report Key: 8275199
• MDR Text Key: 134077002
• Report Number: 3010617000-2019-00044
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1