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 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event of "the autopulse platform (sn (b)(4)) displaying ua45 (not at "home" position after power-on/restart) error message was confirmed through functional testing and archive data review.The root cause for the reported issue was due to user error.Upon visual inspection, observed cracked front cover and noticed that the encoder drive shaft does not rotate smoothly, exhibits binding and resistance, unrelated to the reported complaint.The top cover was replaced and the clutch plate was deburred to remedy the issue.The physical damage appear to have been caused by user damage.Upon powering on, the platform displayed ua45 (drive shaft not at home position) error code during initial functional testing.The encoder drive shaft was not within the acceptable range.The drive shaft has been rotated to home position to clear the ua45 error message.The archive data review showed occurrence of ua45 (not at "home" position after power-on/restart) error messages on the reported event date.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.The autopulse user guide instructs to clear (ua) 45, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.The user advisory will persist until the driveshaft is returned to its home position.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 autopulse has passed all the testing and meets all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(4).

Event Description

As reported, on (b)(6) 2019, the crew observed ua45 (not at "home" position after power-on/restart) error message and was cleared by the crew.On (b)(6) 2019, while using the autopulse platform (sn (b)(4)) on a male patient, the crew noticed that the lifeband would not retract.Troubleshooting was attempted by realigning the lifeband.However, the platform displayed ua45 error message again.Immediately, the crew reverted to manual cpr.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: 8363606
• MDR Text Key: 137267293
• Report Number: 3010617000-2019-00089
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/07/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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