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

Model Number	MODEL 100
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
During patient use, customer reported that the lifeband clip would not fit properly into the driveshaft slot of the autopulse platform (serial #(b)(4)).The lifeband has gone off hook several times.No damage was observed on the driveshaft area of the autopulse.Customer tried using with multiple lifebands with no success.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.
Additional Manufacturer Narrative
The reported complaint of the lifeband clip would not fit properly into the driveshaft slot of the autopulse platform (serial #(b)(6)) was not confirmed during functional testing.When the lifeband was inserted, the lifeband clip (small black rod) did hold properly into the drive shaft slot and no excessive lateral movement was noticed in the encoder driveshaft that could make the lifeband clip to come out.As a precautionary measure, the belt clip retainer and belt clip plate switch bracket will be be replaced to address the reported issue.Upon visual inspection, no physical damage was observed.During archive data review, no discrepancy recorded.During functional testing using manikin, the autopulse platform displayed user advisory "(ua)17" ((max motor on time exceeded during active operation) error message.The root cause of ua17 error message was due to a defective drive train motor, likely attributed to normal wear and tear and the observed ua17 error is unrelated to the reported complaint.The drive train motor needs to be replaced to address ua17 error.The autopulse was manufactured in june 2008 and is 12 years old, well past beyond its service life of 5 years.Also, while during functional testing, the user interface (ui) was damaged by the manikin.The ui window & user interface needs to be replaced to address this issue.Waiting on customer's approval for service repair.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10405967
• Report Number: 3010617000-2020-00782
• Device Sequence Number: 16958200
• 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): 01/08/2021

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: 09/09/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 01/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1