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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(4)) will not power on due to broken battery connector was confirmed during functional testing and visual inspection.The probable root cause is due to a damaged battery cable connector.The possible root cause was due to the user slammed or forcibly inserted the batteries in to the autopulse platforms battery compartment which caused the connector to get damaged, as a result of user mishandling.During visual inspection, the platform was observed with the drive shaft exhibiting binding and resistance and has a damaged bearing.The root cause for the sticky clutch was due to normal wear and tear.In addition, the head restraint wire was frayed, torn load plate cover, cracked bottom cover and damaged coil in the pcb board were observed.Root cause was likely attributed to mishandling such as a drop.These observations were not related to the reported complaint.The autopulse platform is reusable device and was manufactured in 18 jan 2008 and is 12 years old, past the expected service life of five years.There was no preventive maintenance performed since 2012.Unable to download archive due to the damaged battery connector.During functional testing, platform was unable to power on due to the battery would not seat in fully and in further visual inspection it was observed that the battery connector was damaged.The platform is unrepairable due to excessive damage.Historical records were reviewed for service information related to the reported complaint and there was no similar history of complaint reported for autopulse with serial number (b)(4).
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) will not power on due to the autopulse li-ion battery was unable to be fully inserted in the battery bay.The user observed a broken battery connector inside the battery bay.No patient involvement.
Additional Manufacturer Narrative
The autopulse platform (sn (b)(4) was serviced on (b)(6) 2020.After replacing encoder drive shaft, top enclosure, load plate cover, bottom cover, battery compartment and pcb board, 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.

• 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: 10252499
• Report Number: 3010617000-2020-00669
• Device Sequence Number: 19477377
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 10/02/2020

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1