MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the product is returned and the investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr" error message.No patient involvement.
Additional Manufacturer Narrative
The report of the autopulse platform (sn (b)(6) displaying a system error, out of service, revert to manual cpr message was confirmed during the archive data review but not during the functional testing.The investigation findings revealed that the root cause of the reported system error was due to a damaged drive train motor as a result of wear and tear.The autopulse platform was manufactured on 25 july 2008 and it is 12 years old, past beyond its expected serviceable life of 5 years.During visual inspection, a cracked front enclosure and lcd has missing pixels were observed on the returned autopulse platform.This type of physical damage likely attributed to wear and tear and/or mishandling, such as drop.The front enclosure and lcd screen needs to be replaced to address the observed damage.In addition, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.The sticky clutch plate was deburred to address the issue.The cause for the sticky clutch could be due to normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.These observations are not related to the reported complaint.During archive data review, user advisory (ua) 17 (compression tracking error) and ua 2 (compression tracking error) error message.The root cause of the ua 17 and ua 2 were due to a defective drive train.Followed by a system error 139 (unable to hold compression position), thus confirming the reported complaint.In addition, unrelated to the reported complaint, noticed ua 7 (discrepancy between load 1 and load 2 too large) error message.The probable root cause for ua 7 due to the patient not oriented on the autopulse platform correctly or the patient has shifted during compression or take-up.User advisory is a clearable error message, per the autopulse maintenance guide, ua7 is an indication that the patient is out of position or the patient is not properly centered.To clear the error message, the operator needs to ensure that the patient is properly aligned (armpits on the yellow line) and press restart to clear the ua.During initial functional testing, the reported "system error, out of service, revert to manual cpr" error message was not confirmed, however, the platform displayed ua 2 and ua17 error messages, likely related to the reported complaint.The damaged drive train motor needs to be replaced to address the faults.Waiting for customer's approval for service.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 sn (b)(6).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11084916
• Report Number: 3010617000-2020-01313
• Device Sequence Number: 14472570
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: 12/29/2020
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1