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

Model Number	MODEL 100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of "the autopulse platform (sn (b)(4)) stopped compressions" was confirmed during the archive data review but not during the initial functional testing.The root cause for the reported issue was due to the defective encoder.Upon visual inspection, no physical damage was observed.The encoder drive shaft does not rotate smoothly, exhibited binding and resistance.The autopulse platform passed the initial functional testing without any fault or error.The archive data review showed occurrence of user advisory (ua) 27 (encoder fault) and ua45 (not at "home" position after power-on/restart) error messages on the reported event date.Per archive, the autopulse platform performed 591 compression and then stopped due to ua27 (encoder fault).The user powered off the platform.After 5 minutes, the autopulse platform was powered on and displayed ua45 (not at "home" position after power-on/restart) error message.The autopulse platform stopped compression due to the encoder indicates the drive shaft is turning too fast at the speed higher than 3000 rpm during compression.The encoder was defective and requires to be replaced to remedy the issue.The ua45 will persist until the driveshaft is returned to its home position.Incoming visual inspection confirmed the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.This will make it difficult for the user to manually rotate the driveshaft to its home position.After deburring the clutch plate, the drive shaft still does not rotate freely.The clutch plate requires to be replaced to remedy the issue.Further reviewing the archive, there were multiple ua07 (discrepancy between load 1 and load 2 too large) error messages displayed by the platform, unrelated to the reported complaint.The load sensing system has detected a weight or load imbalance between the two load cells, checked during power-on-self-test.The load cell characterization test was performed.The result indicated load cell module 1 was defective.The load cell module 1 requires to be replaced to remedy the issue.Upon customer approval, the defective parts will be replaced and the autopulse platform will be further tested to full 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 or Problem Description
During patient use, the autopulse platform (sn (b)(4)) stopped compressions after an unknown period of time and displayed unknown user advisory (ua) error message.The user was unable to clear the error message.The platform was checked by (b)(4) technician.During testing at (b)(4), the autopulse platform stopped compressions after performing compressions for about 8 minutes and displayed ua45 (not at "home" position after power-on/restart) error message.The user experienced difficulty in removing the lifeband from the platform and the shaft was very heavy to rotate manually.After re-positioning the lifeband to the home position, the platform was restarted.No known impact or consequence to patient information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8506336
• Report Number: 3010617000-2019-00289
• Device Sequence Number: 1839339
• Product Code: DRM
• UDI-Device Identifier: 00849111000550
• UDI-Public: 00849111000550
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1