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

Model Number	MODEL 100
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during the shift check, the autopulse platform (b)(4) did not power up using the fully charged autopulse li-ion batteries (b)(4) and (b)(4).The customer stated that the battery was fully charged before using it with the autopulse platform, and the customer could not provide information on the status leds.The customer stated that they did not have another li-ion battery to test the autopulse platform.In addition, the customer reported a broken head restraint on the autopulse platform.No patient involvement.Please see the following related mfr report: mfr 3010617000-2022-01755 for the autopulse li-ion battery (b)(4).Mfr 3010617000-2022-01856 for the autopulse li-ion battery (b)(4).
Additional Manufacturer Narrative
Zoll has not received the autopulse platform for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.
Additional Manufacturer Narrative
The customer reported a complaint that "the autopulse platform (sn (b)(6)) did not power up using the fully charged autopulse li-ion batteries" was not confirmed during the functional testing and the archive data review.The batteries used during the reported event were not returned to zoll for investigation.No device malfunction was observed during the testing, and the autopulse platform functioned as intended using the known good test batteries.The probable root cause of the customer-reported complaint could be the battery failure.The customer reported a complaint that "the head restraint on the autopulse platform was broken," which was confirmed during the visual inspection.The photo provided by the zoll service personnel revealed that one of the head restraints was cut from the top cover of the autopulse platform.The cut head restraint does not render the autopulse platform non-functional.The patient's head restraint wire could have been cut to free the patient from the platform, or the user could have been lifting the platform by holding the head restraints, which is likely attributed to user mishandling.The top cover was replaced to address the reported complaint.Further visual inspection of the returned autopulse platform revealed a broken screw holder on the front enclosure and a hole on the load plate cover that affects the watertight seal, likely attributed to user mishandling.The observed additional physical damages are unrelated to the reported complaint.The front enclosure and the load plate cover were replaced to address the observed physical damages.In addition, unrelated to the reported complaint, the power distribution board (pdb) revision was found to be old and was replaced.The autopulse passed the initial functional test without any fault or error, and the archive data indicated no significant discrepancies.A load cell characterization test confirmed that both cell modules function within the specification.Following service, the brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed the final run-in test without any fault or error.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15545729
• Report Number: 3010617000-2022-01708
• Device Sequence Number: 5635566
• Product Code: DRM
• UDI-Device Identifier: 00849111000598
• UDI-Public: 00849111000598
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2022

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: 8700-0730-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown