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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the investigation has been completed.
Event or Problem Description
As reported, during patient use, the autopulse platform (sn (b)(4)) stopped compressions after displaying ua16 (timeout moving to take-up position) error message.The user was unable to resolve the issue by resetting or replacing the lifeband.No known impact or consequence to patient information was available.
Additional Manufacturer Narrative
The reported event of "the autopulse platform (sn (b)(4) stopped compressions and displayed user advisory (ua) 16 (timeout moving to take-up position) error message" was confirmed during the archive data review.The root cause for the reported issue was due to the defective drive train motor.Upon visual inspection, observed that the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.Also noticed cracked front cover, unrelated to the reported complaint.The physical damage appear to have been caused by user mishandling.During initial functional testing, the autopulse platform failed due to ua18 (max take-up revolutions exceeded) error message, unrelated to the reported complaint.No load change was detected at the load plate.The autopulse has detected that either the patient's chest was too small while sizing the patient (take up) or that no patient on the platform.Load cell characterization confirmed that both cell modules are defective.The load cell modules requires to be replaced to remedy the issue.The archive data review showed occurrence of multiple ua16 (timeout moving to take-up position) and ua18 (max take-up revolutions exceeded) on the reported event date.The autopulse did not achieve the target depth for take-up within the specified time (~5 secs) due to the defective drive train motor.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 previous history of complaint reported for autopulse platform with serial number (b)(4).

• 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: 8421181
• Report Number: 3010617000-2019-00189
• Device Sequence Number: 13528886
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 04/15/2019

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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1